Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

Breast Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00896649
• Study type: Interventional
• Source: Boston Medical Center
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2009
• Completion date: January 2016