Diagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies
Completed
- Conditions
- breast cancerbreast neoplasm10006291
- Registration Number
- NL-OMON47752
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
Participants of Dutch breast cancer screening with a BI-RADS 0 mammography result, who are referred to one of the participating hospitals for further diagnostic work-up.
Exclusion Criteria
Inability to understand study information
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the accuracy of different imaging strategies in<br /><br>diagnosing breast cancer, expressed as the area under the receiver operating<br /><br>characteristic (ROC) curve. Pathology or the results of all imaging modalities<br /><br>are used as the reference standard. All study participants will be followed up<br /><br>to the next scheduled screening round approximately 2 years later to determine<br /><br>if any breast cancer was missed. The imaging modalities under study,<br /><br>supplemental to the full-field digital screening mammography, are 3DUS, digital<br /><br>breast tomosynthesis (DBT) and handheld ultrasound (HHUS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The diagnostic accuracy of the different imaging strategies among subgroups of<br /><br>patients based on mammographic density and age.<br /><br>The biopsy referral rate for the different imaging strategies under study.<br /><br>The interobserver reliability for 3DUS.</p><br>