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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: digital mammography
* Procedure: positron emission mammography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: PEM
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positron emission mammography<br>questionnaire administration digital mammography positron emission mammography | Other: questionnaire administration<br>* Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.<br>Procedure: digital mammography<br>* standard screening mammogram<br>Procedure: positron emission mammography<br>* one-time positron emission mammography to compare recall rates with that of standard mammogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = normal = abnormal, with no malignancy = abnormal, likely benign = abnormal, likely malignant = malignant | immediately at completion of mammogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer