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Trial record 1 of 1 for:    NCT00896649
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Positron Emission Mammography and Standard Mammography in Women With Dense Breast Tissue or Who Are at High Risk of Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00896649
First received: May 9, 2009
Last updated: July 6, 2012
Last verified: June 2012
History of Changes
  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 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: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Frequency of recall from screening to evaluate a focal image abnormality on each study alone and in combination based on the Breast Imaging Assessment Reporting and Data System (BI-RADS) assessment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Cancer detection rate for each study alone and in combination [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Estimated radiation dose to the breast with each study and in combination [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Incidence of positive studies requiring biopsy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Patient satisfaction level as pertaining to comfort and pain for each study [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896649

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00896649     History of Changes
Other Study ID Numbers: CDR0000640404, BUMC-H-27136, CDMRP #W81XWH-06-1-0309, 05063002, HRPO #A-13777.2
Study First Received: May 9, 2009
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
breast cancer

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

ClinicalTrials.gov processed this record on May 22, 2013