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 with dense breast tissue or who are at high risk of breast cancer.
Other: questionnaire administration
Procedure: digital mammography
Procedure: positron emission mammography
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|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|
- Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs BI-RAD "0" in PEM [ Time Frame: immediately at completion of mammogram ] [ Designated as safety issue: No ]
Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with BI-RAD "0" in PEM
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
- Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study [ Time Frame: One month ] [ Designated as safety issue: No ]Number of participants satisfied with PEM 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.
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2017|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: PEM Imaging
questionnaire administration digital mammography positron emission mammography
Other: questionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.Procedure: digital mammography
standard screening mammogramProcedure: positron emission mammography
one-time PEM to compare recall rates with that of standard mammogram
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896649
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Gustavo Mercier, MD, PhD||Boston Medical Center|