Trial Outcomes & Findings for PET/MR in Surgical Planning for Breast CA Treated With Neoadj Chemo (NCT NCT04149353)
NCT ID: NCT04149353
Last Updated: 2020-06-16
Results Overview
Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.
TERMINATED
NA
1 participants
Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.
2020-06-16
Participant Flow
Participant milestones
| Measure |
Breast Cancer Patients
Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Breast Cancer Patients
Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
|
|---|---|
|
Overall Study
Study terminated
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Breast Cancer Patients
n=1 Participants
Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 0 • n=1 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
|
Pre-surgery PET-MR scan tumor size
|
4 millimeters
STANDARD_DEVIATION 0 • n=1 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.Population: Single subject did not complete the second scan, so outcome measure could not be assessed.
Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.Population: Single subject did not complete the second scan, so outcome measure could not be assessed.
Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach.
Outcome measures
Outcome data not reported
Adverse Events
Breast Cancer Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place