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

Boston Medical Center (BMC)

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: positron emission mammography; Other: questionnaire administration; Procedure: digital mammography

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00896649

CDR0000640404

HRPO #A-13777.2 (Other Identifier)

BUMC-H-27136 (Other Identifier)

W81XWH-06-1-0309 (Other Identifier)

05063002 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 193 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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193 participants in 1 patient group

positron emission mammography

Experimental group

Description:

questionnaire administration digital mammography positron emission mammography

Treatment:

Procedure: positron emission mammography

Procedure: digital mammography

Other: questionnaire administration