Trial Outcomes & Findings for 18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma (NCT NCT00775268)

Last Updated: 2021-03-11

Results Overview

A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to 3.5 years

Results posted on

2021-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Scanned at Baseline & After Chemotherapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans	Participants Scanned in the Evaluation of Residual Masses After Therapy Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected
Baseline STARTED	9	22
Baseline COMPLETED	8	21
Baseline NOT COMPLETED	1	1
After 2 Cycles STARTED	8	0
After 2 Cycles COMPLETED	7	0
After 2 Cycles NOT COMPLETED	1	0
After Completion STARTED	7	0
After Completion COMPLETED	6	0
After Completion NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Scanned at Baseline & After Chemotherapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans	Participants Scanned in the Evaluation of Residual Masses After Therapy Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected
Baseline Drug not synthesize dose	1	0
Baseline Not treated-ineligible per CT	0	1
After 2 Cycles Participant refused to be scanned further	1	0
After Completion Participant missed scan appointment	1	0

Baseline Characteristics

Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Scanned at Baseline & After Chemotherapy n=9 Participants Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans	Participants Scanned in the Evaluation of Residual Masses After Therapy n=22 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=9 Participants	18 Participants n=22 Participants	26 Participants n=31 Participants
Age, Categorical >=65 years	1 Participants n=9 Participants	4 Participants n=22 Participants	5 Participants n=31 Participants
Age, Continuous	49.3 years STANDARD_DEVIATION 13.0 • n=9 Participants	48.0 years STANDARD_DEVIATION 17.3 • n=22 Participants	48.4 years STANDARD_DEVIATION 16.1 • n=31 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	12 Participants n=22 Participants	15 Participants n=31 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	10 Participants n=22 Participants	16 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	1 Participants n=22 Participants	1 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants	21 Participants n=22 Participants	30 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	1 Participants n=22 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	4 Participants n=22 Participants	4 Participants n=31 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants	17 Participants n=22 Participants	26 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=22 Participants	0 Participants n=31 Participants
Region of Enrollment United States	9 participants n=9 Participants	22 participants n=22 Participants	31 participants n=31 Participants
Diagnosis Non-Hodgkin's Lymphoma	6 participants n=9 Participants	17 participants n=22 Participants	23 participants n=31 Participants
Diagnosis Hodgkin's Lymphoma	3 participants n=9 Participants	5 participants n=22 Participants	8 participants n=31 Participants
Residual Mass Size Patient 1-Right hilum lymph node	—	2.4 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.4 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 2-Superior mediastinal lymph node	—	2.4 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.4 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 3-Lumbar vertebrae	—	2.5 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.5 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 4-Right pelvic mass	—	9.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	9.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 5-Intercostal soft tissue mass	—	2.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 6-Right cervical lymph node	—	3.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	3.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 7-Anterior mediastinal mass	—	2.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 8-Anterior mediastinal mass	—	6.8 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	6.8 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 9-Internal right iliac lymph node	—	2.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 10-Right pelvic mass	—	2.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 11-Right paratracheal lymph node	—	2.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 12-Left inguinal lymph node	—	1.6 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	1.6 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 13-Left axilla lymph node	—	3.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	3.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 14-Gastrohepatic lymph node	—	2.8 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.8 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 15-Right posterior thigh mass	—	2.5 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.5 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 16-Left abdominal mass	—	8.0 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	8 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 17-Left suprarenal mass	—	4.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	4.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 18-Splenic mass	—	2.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.3 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 19-Right paraaortic lymph node	—	2.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	2.7 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 20-Right hilum lymph node	—	1.6 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	1.6 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.
Residual Mass Size Patient 21-Mesenteric mass	—	5.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.	5.2 cm n=1 Participants • Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.

PRIMARY outcome

Timeframe: Up to 3.5 years

Population: 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data was collected for only the Arm/Group of participants with residual masses.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=21 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy Presence of FLT uptake	9 Participants	—
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy Absence of FLT uptake and FLT uptake lower than normal mediastinum	12 Participants	—
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy Positive Biopsy	7 Participants	—
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy Negative Biopsy	4 Participants	—
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy Biopsy not performed	10 Participants	—

SECONDARY outcome

Timeframe: up to 4.5 years

Population: 8/9 participants were analyzed at baseline because the FLT dose failed synthesis in 1 participant. 6/9 participants were analyzed at completion of therapy because 1 participant refused to be imaged, 1 participant missed scan appointment, and 1 patient's FLT dose failed synthesis at baseline and was not scanned at completion of therapy either The rows at baseline and completion of therapy represent the pts: 8 patients were scanned at baseline and 6 pts were scanned at completion of therapy.

FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=8 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans Baseline	9.15 SUVmax Standard Deviation 2.84	—
18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans Completion of therapy scans	0.9 SUVmax Standard Deviation 0.20	—

SECONDARY outcome

Timeframe: up to 4.5 years

Population: 8/9 participants were analyzed at baseline and 6/9 were analyzed after completion of therapy because 6 patients completed the 3 scans (baseline, at 2-cycles and after completion of therapy). This outcome measure data is collected only for one of the Arm/Group. The other group of participants were not scanned at baseline and after treatment. This data is for baseline (8 patients) and after therapy (6 patients). The outcome measure refers to baseline and after completion of therapy.

The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=8 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients Baseline	9.1 Standard Uptake Value (SUV) - units Standard Deviation 2.8	—
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients After completion of scan	1.5 Standard Uptake Value (SUV) - units Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: Up to 4.5 years

Population: 6/9 participants were analyzed after completion of therapy because the FLT dose failed synthesis in 1 participant at baseline and was not scanned at completion, 1 participant refused to be imaged and 1 participant missed scan appointment. The other group of participants were not scanned at baseline and after treatment.

The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s).

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=6 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy n=6 Participants Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 3	10.3 SUV	1.3 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 1	10.9 SUV	0.9 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 2	4.8 SUV	1.0 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 4	9.1 SUV	0.9 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 5	9.3 SUV	0.6 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Patient 6	9.2 SUV	0.9 SUV
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) Group-level (at baseline and after completion of therapy)	9.2 SUV Standard Deviation 1.9	0.9 SUV Standard Deviation 0.2

SECONDARY outcome

Timeframe: up to 3.5 years

Population: 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data collected only from residual mass Group of patients for this Outcome Measure.

After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=21 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 7	5.4 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 1	4.6 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 2	8.4 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 3	10.1 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 4	3.8 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 5	6.9 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 6	6.7 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 8	4.7 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 9	4.6 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 10	10.3 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 11	4.8 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 12	3.8 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 13	4.0 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 14	6.9 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 15	6.4 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 16	15.8 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 17	11.2 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 18	2.1 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 19	3.8 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 20	3.5 SUVmax/Tumor blood ratio	—
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection Patient 21	9.1 SUVmax/Tumor blood ratio	—

SECONDARY outcome

Timeframe: up to 3.5 years

Population: This outcome measure was collected for Arm/Group of patients with residual tumor masses after therapy. 21/22 participants were analyzed in thisArm/Group because one participant was not scanned with FLT, ineligible per CT criteria. 18/21 were analyzed in the second Arm/Group because no scans were available for three participants at 2 hours post injection.

The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=21 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy n=18 Participants Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 1	0.7 SUV	NA SUV The 2 hour scan was not acquired.
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 6	7.5 SUV	4.6 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 2	2.0 SUV	1.8 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 3	8.9 SUV	NA SUV The 2 hour scan was not acquired.
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 4	1.6 SUV	0.8 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 5	1.3 SUV	7.9 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 7	3.4 SUV	3.2 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 8	1.6 SUV	1.2 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 9	6.5 SUV	6.0 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 10	2.3 SUV	2.0 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 11	2.5 SUV	2.4 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 12	2.2 SUV	1.5 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 13	7.6 SUV	7.4 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 14	4.5 SUV	4.2 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 15	1.9 SUV	1.6 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 16	3.9 SUV	3.6 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 17	4.7 SUV	4.5 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 18	7.9 SUV	7.9 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 19	1.1 SUV	1.1 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 20	1.5 SUV	NA SUV The 2 hour scan was not acquired.
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Patient 21	6.4 SUV	5.4 SUV
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection Overall participants	3.6 SUV Standard Deviation 2.5	2.9 SUV Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to 4.5 years

Population: 8/9 participants were analyzed because the FLT dose failed synthesis in 1 participant, 1 participant refused to be imaged.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=8 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan 2-cycles post treatment	1.5 SUVmax Standard Deviation 0.63	—
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan Baseline	9.15 SUVmax Standard Deviation 2.84	—

SECONDARY outcome

Timeframe: up to 4.5 years

Population: 3/6 participants were analyzed because 3 did not progress while on study. Data collected only from the Group of patients scanned at baseline and after chemotherapy for this Outcome Measure.

The time to progression (defined as time in months from 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value).

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=3 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Time to Progression	18.29 Months Standard Deviation 8.0	—

SECONDARY outcome

Timeframe: up to 4.5 years

FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax).

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=21 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy Malignant Lesions	5.5 SUVmax Standard Deviation 2.2	—
18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy Benign Lesions	1.7 SUVmax Standard Deviation 0.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.

Population: 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group.

Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Participants Scanned in the Evaluation of Residual Masses After Therapy n=8 Participants Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected	Participants Scanned After Completion of Therapy n=21 Participants Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	7 Participants	20 Participants

Adverse Events

Participants Scanned at Baseline & After Chemotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 3 deaths

Participants Scanned in the Evaluation of Residual Masses After Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants Scanned at Baseline & After Chemotherapy n=8 participants at risk Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans	Participants Scanned in the Evaluation of Residual Masses After Therapy n=21 participants at risk Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected fine-needle aspiration: sample collected
Cardiac disorders Chest pain - cardiac	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. The risk can only be for 8 patients and 21 participants who received FLT scan.	0.00% 0/21 • Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. The risk can only be for 8 patients and 21 participants who received FLT scan.
Gastrointestinal disorders Nausea	0.00% 0/8 • Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. The risk can only be for 8 patients and 21 participants who received FLT scan.	4.8% 1/21 • Number of events 1 • Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. The risk can only be for 8 patients and 21 participants who received FLT scan.

Additional Information

Dr. Esther Mena

National Cancer Institute

Phone: 240-760-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place