Impact of Dedicated Breast Positron Emission Mammography vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Medical Center
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography
Study Overview
Brief Summary
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors.
PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.
Detailed Description
OBJECTIVES:
- To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration.
- To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography.
- To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain.
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 positron emission mammography.
After completion of study treatment, patients are followed annually.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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:
- •Haitian Creole
- •African American
- •Caucasian
- •PRIOR CONCURRENT THERAPY:
- •None specified
Exclusion Criteria
- •No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
Arms & Interventions
positron emission mammography
questionnaire administration digital mammography positron emission mammography
Intervention: questionnaire administration (Other)
positron emission mammography
questionnaire administration digital mammography positron emission mammography
Intervention: digital mammography (Procedure)
positron emission mammography
questionnaire administration digital mammography positron emission mammography
Intervention: positron emission mammography (Procedure)
Outcomes
Primary Outcomes
Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography
Time Frame: immediately at completion of mammogram
Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant
Secondary Outcomes
- Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study(One month)
Investigators
Gustavo Mercier
BMC Attending Physician
Boston Medical Center