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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: digital mammography; Procedure: positron emission mammography

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 Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Gustavo Mercier, MD, PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CDR0000640404; BUMC-H-27136 (Other Identifier: BUMC IRB); W81XWH-06-1-0309 (Other Identifier: funding number); 05063002 (Other Identifier); HRPO #A-13777.2 (Other Identifier: DoD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data is not useful.