Diagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies
- Conditions
- Breast NeoplasmsBreast CancerBreast UltrasonographyThree-dimensional UltrasoundBorstkankerMammacarcinoomEchografie MammaeDriedimensionale Echografie
- Registration Number
- NL-OMON29659
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
Dutch breast cancer screening participants aged 50-75 years
- BI-RADS 0 screening mammography result
Exclusion Criteria
- Subject is unable to understand, read and sign the study specific informed consent after the nature of the study has been fully explained to her.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the accuracy of different imaging strategies in diagnosing breast cancer, expressed as the area under the receiver operating characteristic (ROC) curve. Pathology or the results of all imaging modalities are used as the reference standard. All study participants will be followed up to the next scheduled screening round approximately 2 years later to determine if any breast cancer was missed. The imaging modalities under study, supplemental to the full-field digital screening mammography, are 3DUS, digital breast tomosynthesis and handheld ultrasound.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include the diagnostic accuracy of the different imaging studies for subgroups of patients based on age and mammographic density. Furthermore, the biopsy referral rate for the different imaging strategies and the interobserver reliability for 3DUS will be determined.