Trial Outcomes & Findings for PET/CT Evaluation of Treatment Response in Breast Cancer (NCT NCT01222416)

Last Updated: 2017-07-02

Results Overview

The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the

Recruitment status

TERMINATED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)

Results posted on

2017-07-02

Participant Flow

This trial opened to accrual on 10/13/2010 and closed to accrual on 4/14/2015.

No participants were enrolled onto the Fluorodeoxythymidine PET/CT (FLT-PET/CT) arm because this trial closed to accrual early due to slow accrual.

Participant milestones

Participant milestones
Measure	Fluorodeoxyglucose PET/CT (FDG-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical Administration \[18F\]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.	Fluorodeoxythymidine PET/CT (FLT-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical: \[18F\]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Overall Study STARTED	50	0
Overall Study COMPLETED	30	0
Overall Study NOT COMPLETED	20	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluorodeoxyglucose PET/CT (FDG-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical Administration \[18F\]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.	Fluorodeoxythymidine PET/CT (FLT-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical: \[18F\]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Overall Study ineligible;metastasis	3	0
Overall Study Adverse Event	4	0
Overall Study Withdrawal by Subject	5	0
Overall Study scheduling	6	0
Overall Study missed view/scan	1	0
Overall Study Death	1	0

Baseline Characteristics

PET/CT Evaluation of Treatment Response in Breast Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)

Population: 19 Patients had the scanned data at two time points: prior treatment and at the end of treatment.

Outcome measures

Outcome measures
Measure	Fluorodeoxyglucose PET/CT (FDG-PET/CT) n=19 Participants A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical Administration \[18F\]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.	Fluorodeoxythymidine PET/CT (FLT-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical: \[18F\]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) Difference in SULpeak change, prone	1.23 microcuries/g/(millicuries/kg) Interval -2.01 to 3.82	—
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) Difference in SULmax change, prone	2.12 microcuries/g/(millicuries/kg) Interval -1.87 to 4.45	—
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) Difference in SULpeak change, supine	1.89 microcuries/g/(millicuries/kg) Interval -1.37 to 4.7	—
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) Difference in SULmax change, supine	2.88 microcuries/g/(millicuries/kg) Interval -1.53 to 5.93	—

SECONDARY outcome

Timeframe: 48 months

Population: There were insufficient number of patients who had both MRI and PET performed to allow for meaningful statistical comparisons.

Outcome measures

Outcome data not reported

Adverse Events

Fluorodeoxyglucose PET/CT (FDG-PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluorodeoxythymidine PET/CT (FLT-PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

A Bapsi Chakravarthy, MD Program Director, Radiation Oncology

Vanderbilt-Ingram Cancer Center

Phone: 615-322-2555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fluorodeoxyglucose PET/CT (FDG-PET/CT) n=50 Participants A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical Administration \[18F\]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.	Fluorodeoxythymidine PET/CT (FLT-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Radiopharmaceutical: \[18F\]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	—	46 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	—	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	—	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	—	11 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	—	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	—	50 participants n=5 Participants