Three-dimensional bREast ultraSound for resPOnse evaluation of Neo-aDjuvant chEmotheRapy; an adequate replacement for MRI in breast cancer patients? (RESPONDER trial)
Recruiting
- Conditions
- Breast cancer, neoadjuvant chemotherapy, tumour response evaluation
- Registration Number
- NL-OMON20208
- Lead Sponsor
- Erasmus Medical Centre, Cancer Institute<br>Erasmus Medical Centre, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
Female
Aged > 18 year
Exclusion Criteria
T4 breast cancer stadium (i.e. tumor of any size growing in to the chest wall or skin)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance between longest tumour diameter during response evaluation. Longest diameter will be accessed and compared between the (conventional) MRI and the ABVS.
- Secondary Outcome Measures
Name Time Method 1) The concordance of volume (instead of longest diameter) response evaluation of the (conventional) MRI and the ABVS;<br /><br>2) The diagnostic accuracy of the ABVS to predict a pathologic complete response; <br /><br>3) Patients preferences as measured by a questionnaire;<br /><br>4) The costs of the response evaluation by the (conventional) MRI as compared to the ABVS.<br>