Back to resultsRole of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEM Flex Solo II PET Scanner
MRI scan
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Exclusion Criteria:
- Children (< 18 years old)
- Pregnant or Lactating women
- Diabetic patients (Type I or II)
- Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
- Patients who have NOT undergone a standard of care bilateral breast MRI
Sites / Locations
- The University of Chicago Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Beast cancer subjects
Arm Description
Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Outcomes
Primary Outcome Measures
Reduction in Tumor Size
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012440
Brief Title
Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Official Title
Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beast cancer subjects
Arm Type
Experimental
Arm Description
Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Intervention Type
Device
Intervention Name(s)
PEM Flex Solo II PET Scanner
Intervention Description
Subjects will receive bilateral (both sides) breast and axillary PEM scans.
Intervention Type
Device
Intervention Name(s)
MRI scan
Intervention Description
Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Primary Outcome Measure Information:
Title
Reduction in Tumor Size
Description
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.
Time Frame
1-2 weeks post treatment onset
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Exclusion Criteria:
Children (< 18 years old)
Pregnant or Lactating women
Diabetic patients (Type I or II)
Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
Patients who have NOT undergone a standard of care bilateral breast MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirti Kulkarni, M.D.
Organizational Affiliation
The University of Chicago Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
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