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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00896649
• Other study ID #: CDR0000640404
• Secondary ID: BUMC-H-27136W81X
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 9, 2009
• Last updated: January 28, 2015
• Start date: February 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 with dense breast tissue or who are at high risk of breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: January 2016
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• questionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.

Procedure:
• digital mammography
standard screening mammogram
• positron emission mammography
one-time PEM to compare recall rates with that of standard mammogram

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 week	No
Secondary	Cancer detection rate for each study alone and in combination		One month	No
Secondary	Estimated radiation dose to the breast with each study and in combination		One month	No
Secondary	Incidence of positive studies requiring biopsy		One month	No
Secondary	Patient satisfaction level as pertaining to comfort and pain for each study		One month	No