Trial Outcomes & Findings for Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors (NCT NCT01243333)
NCT ID: NCT01243333
Last Updated: 2024-04-17
Results Overview
The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.
TERMINATED
NA
26 participants
1-2 cycles of treatment - approximately one month
2024-04-17
Participant Flow
Participant milestones
| Measure |
All Patients: Multi-Tracer PET Scans
Patients undergo Positron Emission Tomography (PET) scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
All Patients: Multi-Tracer PET Scans
n=26 Participants
Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 cycles of treatment - approximately one monthThe patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.
Outcome measures
| Measure |
All Patients: Multi-Tracer PET Scans
n=18 Participants
Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
FDG Therapeutic Response
Partial Response (PR)
|
10 Participants
|
|
FDG Therapeutic Response
Stable Disease (SD)
|
8 Participants
|
|
FDG Therapeutic Response
Progressive Disease (PD)
|
0 Participants
|
PRIMARY outcome
Timeframe: 1-2 cycles of treatment - approximately one monthThe patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.
Outcome measures
| Measure |
All Patients: Multi-Tracer PET Scans
n=18 Participants
Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
FLT Therapeutic Response
Partial Response (PR)
|
8 Participants
|
|
FLT Therapeutic Response
Stable Disease (SD)
|
8 Participants
|
|
FLT Therapeutic Response
Progressive Disease (PD)
|
2 Participants
|
PRIMARY outcome
Timeframe: 1-2 cycles of treatment - approximately one monthThe patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes.
Outcome measures
| Measure |
All Patients: Multi-Tracer PET Scans
n=18 Participants
Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
Standard Therapeutic Response
Partial Response (PR)
|
4 Participants
|
|
Standard Therapeutic Response
Stable Disease (SD)
|
10 Participants
|
|
Standard Therapeutic Response
Progressive Disease (PD)
|
4 Participants
|
Adverse Events
All Patients: Multi-Tracer PET Scans
Serious adverse events
| Measure |
All Patients: Multi-Tracer PET Scans
n=26 participants at risk
Patients undergo PET scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other: Death due to disease pr
|
3.8%
1/26
|
Other adverse events
Adverse event data not reported
Additional Information
Josiah Hawks
Huntsman Cancer Institute Research Compliance Officer
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place