Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

193

Study ID:

NCT00896649

Recruitment Status:

Completed

Sponsor:

Boston Medical Center

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There is 1 Location for this study

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Boston University Cancer Research Center
Boston Massachusetts, 02118, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

193

Study ID:

NCT00896649

Recruitment Status:

Completed

Sponsor:


Boston Medical Center

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