Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments questionnaire administration, digital mammography, positron emission mammography
Phase phase 3
Sponsor Boston Medical Center
Collaborator Department of Defense
Start date February 2009
End date July 2012
Trial size 260 participants
Trial identifier NCT00896649, 05063002, BUMC-H-27136, CDR0000640404, HRPO #A-13777.2, W81XWH-06-1-0309

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 with dense breast tissue or who are at high risk of breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
questionnaire administration digital mammography positron emission mammography
questionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.
digital mammography
standard screening mammogram
positron emission mammography
one-time PEM to compare recall rates with that of standard mammogram

Primary Outcomes

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
time frame: 1 week

Secondary Outcomes

Measure
Cancer detection rate for each study alone and in combination
time frame: One month
Estimated radiation dose to the breast with each study and in combination
time frame: One month
Incidence of positive studies requiring biopsy
time frame: One month
Patient satisfaction level as pertaining to comfort and pain for each study
time frame: One month

Eligibility Criteria

Female participants at least 35 years old.

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: - Hispanic - 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

Additional Information

Official title 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
Principal investigator Gustavo Mercier, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Boston Medical Center.