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

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Gustavo Mercier, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00896649
First received: May 9, 2009
Last updated: April 3, 2017
Last verified: April 2017
May 9, 2009
April 3, 2017
February 2009
July 2012   (Final data collection date for primary outcome measure)
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
  • 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
  • Cancer detection rate for each study alone and in combination
  • Estimated radiation dose to the breast with each study and in combination
  • Incidence of positive studies requiring biopsy
  • Total time to interpret each study and the cost of each procedure
  • Patient satisfaction level as pertaining to comfort and pain for each study
Complete list of historical versions of study NCT00896649 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Intervention Model Description:
PEM
Masking: No masking
Primary Purpose: Screening
Breast Cancer
  • 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
Experimental: positron emission mammography
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.
 
Completed
193
January 2017
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
Sexes Eligible for Study: Female
35 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00896649
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 )
Yes
Not Provided
Plan to Share IPD: No
Plan Description: Individual participant data is not useful.
Gustavo Mercier, Boston Medical Center
Boston Medical Center
United States Department of Defense
Principal Investigator: Gustavo Mercier, MD, PhD Boston Medical Center
Boston Medical Center
April 2017

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