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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: questionnaire administration; Procedure: digital mammography; Procedure: positron emission mammography

• Registration Number: NCT00896649
• Lead Sponsor: Boston Medical Center

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2012-07
• Results First Submitted: 2016-05-06
• Results First Submitted QC: 2016-09-13
• Results First Posted: 2016-10-31
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
positron emission mammography	positron emission mammography	questionnaire administration digital mammography positron emission mammography
positron emission mammography	questionnaire administration	questionnaire administration digital mammography positron emission mammography
positron emission mammography	digital mammography	questionnaire administration digital mammography positron emission mammography

Primary Outcome Measures

Name	Time	Method
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	immediately at completion of mammogram	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

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study	One month	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.

Trial Locations

Locations (1)

Boston University Cancer Research Center; 🇺🇸 Boston, Massachusetts, United States