Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00896649|
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : October 31, 2016
Last Update Posted : May 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: questionnaire administration Procedure: digital mammography Procedure: positron emission mammography||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||PEM|
|Masking:||None (Open Label)|
|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 Start Date :||February 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||January 2017|
Experimental: positron emission mammography
questionnaire administration digital mammography positron emission mammography
Other: questionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
Procedure: digital mammography
standard screening mammogram
Procedure: positron emission mammography
one-time positron emission mammography to compare recall rates with that of standard mammogram
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896649
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Gustavo Mercier, MD, PhD||Boston Medical Center|