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

Boston Medical Center193 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

193

Conditions

Breast Cancer

Interventions

questionnaire administrationOTHER

Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.

digital mammographyPROCEDURE

standard screening mammogram

positron emission mammographyPROCEDURE

one-time positron emission mammography to compare recall rates with that of standard mammogram

Eligibility

Sex: FEMALEMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Boston University Cancer Research Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography

Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant

Time frame: immediately at completion of mammogram

Secondary Outcomes

Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study

Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.

Time frame: One month

Data from ClinicalTrials.gov

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