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OpenTrials
Completed

NCT Number: NCT00896649

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

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.

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Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.

Digital Mammography

Procedure

standard screening mammogram

positron emission mammography

Procedure

one-time positron emission mammography to compare recall rates with that of standard mammogram

Primary outcomes

  1. 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

    • = normal
    • = abnormal, with no malignancy
    • = abnormal, likely benign
    • = abnormal, likely malignant
    • = malignant

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2017
First posted
May 12, 2009
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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