Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited
subjects chosen for the study will have biopsy proven breast cancer and are eligible for
chemotherapy. They will undergo bilateral breast MRI for staging which is considered
standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or
pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and
PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than
14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM
views will be performed of both the ipsilateral and contralateral breast and axillae by a
Mammography Technologist trained in mammographic positioning.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure response to neoadjuvant chemotherapy in patients with breast cancer.
analysis of three patients pilot data in progress
one and a half years
Kirti Kulkarni, M.D.
The University of Chicago Medical Center
United States: Food and Drug Administration
|The University of Chicago Medical Center||Chicago, Illinois 60637-1470|