Clinical trial NCT00896649: Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-05-12
Enrollment: 193
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PEM
Primary purpose: SCREENING

Brief summary: 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.

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 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

Primary outcomes:
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
timeFrame: immediately at completion of mammogram
Secondary outcomes:
measure: Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study
timeFrame: One month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Gustavo Mercier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: