N/A
N=193
Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00896649 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: 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 — 28; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- questionnaire administration (Other); digital mammography (Procedure); positron emission mammography (Procedure)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Boston Medical Center
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
28; 27 | — |
| SECONDARY Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study |
165; 23; 175; 13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00896649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.