Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
The purpose of this study is:
- To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
- To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer|
- Reduction in tumor size [ Time Frame: 1-2 weeks post treatment onset ] [ Designated as safety issue: No ]Comparison of treatment response assessment methods: PEM vs standard of care MRI
|Study Start Date:||November 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Beast cancer subjects
Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Device: PEM Flex Solo II PET Scanner
Subjects will receive bilateral (both sides) breast and axillary PEM scans.Device: MRI scan
Subjects will receive bilateral (both sides) breast and axillary MRI scans.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012440
|United States, Illinois|
|The University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Kirti Kulkarni, M.D.||The University of Chicago Medical Center|