|Phase III||Health services research, Screening||Closed||35 and over||Other||CDR0000640404|
BUMC-H-27136, CDMRP #W81XWH-06-1-0309, 05063002, HRPO #A-13777.2, H-27136, NCT00896649
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.
Further Study Information
- 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.
- 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
- 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
PRIOR CONCURRENT THERAPY:
- None specified
Trial Lead Organizations/Sponsors
Boston University Cancer Research CenterDepartment of Defense
|Gustavo Mercier||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00896649
Information obtained from ClinicalTrials.gov on November 20, 2012
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