NCT00896649

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
PROCEDURE	digital mammography	standard screening mammogram
PROCEDURE	positron emission mammography	one-time positron emission mammography to compare recall rates with that of standard mammogram

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-07-01
• Completion: 2017-01-01
• First posted: 2009-05-12
• Last updated: 2017-05-09
• Results posted: 2016-10-31

Locations

1 site across 1 country: United States