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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


Phase 3
35 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

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

Outcome Time Frame:

1 week

Safety Issue:

No

Principal Investigator

Gustavo Mercier, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000640404

NCT ID:

NCT00896649

Start Date:

February 2009

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Boston University Cancer Research CenterBoston, Massachusetts  02118