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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896649
First Posted: May 12, 2009
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Gustavo Mercier, Boston Medical Center
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
PEM
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gustavo Mercier, Boston Medical Center:

Primary Outcome Measures:
  • 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 [ 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 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:
  • Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study [ Time Frame: 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.


Enrollment: 193
Study Start Date: February 2009
Study Completion Date: January 2017
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896649


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

Responsible Party: Gustavo Mercier, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov 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 )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Results First Submitted: May 6, 2016
Results First Posted: October 31, 2016
Last Update Posted: May 9, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is not useful.

Keywords provided by Gustavo Mercier, Boston Medical Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases