Impact of Dedicated Breast PET Imaging vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
35 Years
N/A
Female
Breast Cancer
Trial Information
Impact of Dedicated Breast PET Imaging vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
OBJECTIVES:
- To install the breast PET system and to test and ensure its compliance with all
regulatory agencies including the ACR and FDA.
- To measure and compare the number of call-backs for positron emission mammography (PEM)
imaging and conventional mammography, and to calculate the number of true positive and
false positive exams for mammograms and PEM imagining using pathologic results and
yearly follow-up mammogram results (cancer detection rate) in women with dense breast
tissue or at high risk for breast cancer.
- To measure and compare patient satisfaction for both conventional mammography and PEM
in terms of comfort and pain.
- To measure and compare the cost effectiveness with conventional mammography vs PEM by
examining cost, examination time, and radiologist reading time.
OUTLINE: Patients undergo a conventional two-view mammogram and positron emission
mammography (PEM). Immediately following treatment, patients complete a questionnaire on
their satisfaction with the standard mammogram and the PEM.
After completion of study treatment, patients are followed annually.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Scheduled to undergo screening mammogram at one of the Boston Medical
Center-affiliated primary care clinics and meets 1 of the following criteria:
- Dense breast tissue
- At high-risk for breast cancer
- No history of breast cancer, palpable breast mass, abnormal nipple discharge, or
other focal complaints warranting diagnostic mammogram
PATIENT CHARACTERISTICS:
- Has 1 of the following racial or ethnic backgrounds based on the patient's country of
birth or the mother and father's country of birth:
- Hispanic
- Haitian Creole
- African American
- Caucasian
PRIOR CONCURRENT THERAPY:
- None specified
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Frequency of recall from screening to evaluate a focal image abnormality on each study alone and in combination based on the Breast Imaging Assessment Reporting and Data System (BI-RADS) assessment
Outcome Time Frame:
1 week
Safety Issue:
No
Principal Investigator
Gustavo Mercier, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Boston Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000640404
NCT ID:
NCT00896649
Start Date:
February 2009
Completion Date:
January 2013
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
