Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to determine the possible role of PEM imaging in assessing ALN involvement preoperatively in patients with newly diagnosed breast cancer, prior to surgical intervention.
determining the accuracy of FDG positron emission mammography in identifying axillary lymph node metastases from breast cancer
one and a half years
Daniel Appelbaum, M.D.
The University of Chicago Medical Center
United States: Food and Drug Administration
|The University of Chicago Medical Center||Chicago, Illinois 60637-1470|