Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00896649
First received: May 9, 2009
Last updated: January 28, 2015
Last verified: January 2015

May 9, 2009
January 28, 2015
February 2009
July 2012   (final data collection date for primary outcome measure)
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 ]
  • 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 [ Designated as safety issue: No ]
  • Cancer detection rate for each study alone and in combination [ Designated as safety issue: No ]
  • Estimated radiation dose to the breast with each study and in combination [ Designated as safety issue: No ]
  • Incidence of positive studies requiring biopsy [ Designated as safety issue: No ]
  • Patient satisfaction level as pertaining to comfort and pain for each study [ Designated as safety issue: No ]
  • Total time to interpret each study and the cost of each procedure [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00896649 on ClinicalTrials.gov Archive Site
  • Cancer detection rate for each study alone and in combination [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Estimated radiation dose to the breast with each study and in combination [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Incidence of positive studies requiring biopsy [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Patient satisfaction level as pertaining to comfort and pain for each study [ Time Frame: One month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer
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

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.

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.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Breast Cancer
  • 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
Experimental: PEM Imaging
questionnaire administration digital mammography positron emission mammography
Interventions:
  • Other: questionnaire administration
  • Procedure: digital mammography
  • Procedure: positron emission mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
January 2016
July 2012   (final data collection date for primary outcome measure)

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
Female
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00896649
CDR0000640404, BUMC-H-27136, W81XWH-06-1-0309, 05063002, HRPO #A-13777.2
Yes
Boston Medical Center
Boston Medical Center
Department of Defense
Principal Investigator: Gustavo Mercier, MD, PhD Boston Medical Center
Boston Medical Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP