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Trial record 1 of 1 for:    NCT00896649
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Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

This study is ongoing, but not recruiting participants.
United States Department of Defense
Information provided by (Responsible Party):
Gustavo Mercier, Boston Medical Center Identifier:
First received: May 9, 2009
Last updated: November 1, 2016
Last verified: September 2016

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 with dense breast tissue or who are at high risk of breast cancer.

Condition Intervention Phase
Breast Cancer
Other: questionnaire administration
Procedure: digital mammography
Procedure: positron emission mammography
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Impact of Dedicated Breast PET Imaging vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women

Resource links provided by NLM:

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs BI-RAD "0" in PEM [ Time Frame: 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 BI-RAD "0" in PEM

    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:
  • Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study [ Time Frame: One month ]
    Number of participants satisfied with PEM 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.

Enrollment: 193
Study Start Date: February 2009
Estimated Study Completion Date: January 2017
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEM Imaging
questionnaire administration digital mammography positron emission mammography
Other: questionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.
Procedure: digital mammography
standard screening mammogram
Procedure: positron emission mammography
one-time PEM to compare recall rates with that of standard mammogram

Detailed Description:


  • To install the breast PET system and to test and ensure its compliance with all regulatory agencies including the ACR and FDA.
  • To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography, and to calculate the number of true positive and false positive exams for mammograms and PEM imagining using pathologic results and yearly follow-up mammogram results (cancer detection rate) in women with dense breast tissue or at high risk for breast cancer.
  • To measure and compare patient satisfaction for both conventional mammography and PEM in terms of comfort and pain.
  • To measure and compare the cost effectiveness with conventional mammography vs PEM by examining cost, examination time, and radiologist reading time.

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 PEM.

After completion of study treatment, patients are followed annually.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria:


  • 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


  • 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


  • None specified

Exclusion criteria:

  • No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
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Please refer to this study by its identifier: NCT00896649

United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
United States Department of Defense
Principal Investigator: Gustavo Mercier, MD, PhD Boston Medical Center
  More Information

Responsible Party: Gustavo Mercier, BMC Attending Physician, Boston Medical Center Identifier: NCT00896649     History of Changes
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 )
Study First Received: May 9, 2009
Results First Received: May 6, 2016
Last Updated: November 1, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Individual participant data is not useful.

Keywords provided by Boston Medical Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 28, 2017