Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
|ClinicalTrials.gov Identifier: NCT01012440|
Recruitment Status : Terminated (Poor accrual)
First Posted : November 13, 2009
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: PEM Flex Solo II PET Scanner Device: MRI scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2012|
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.
- Reduction in Tumor Size [ Time Frame: 1-2 weeks post treatment onset ]Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|