Feasibility of 3D Breast Ultrasound in comparison with 3D breast MRI Amendement: Analysis of false positive rate with 3D ultrasound
Completed
- Conditions
- Breast neoplasmata1000629110006232
- Registration Number
- NL-OMON36527
- Lead Sponsor
- Jeroen Bosch Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
All patients who are scheduled for MRI of the breast in accordance of current practice in the Jeroen Bosch Hospital will be invited to participate. Inclusion period will be approximatly 3 months.
Amendement: Additionally patients will be included who are scheduled for a routine mammography
Exclusion Criteria
1.Patients who are unable to provide informed consent; 2.Patients who cannot undergo adequate examination with breast ultrasound and MRI or who are unable to cooperate; 3.Patients who, for logistic reasons, cannot be examined by ABVS within a period of one week prior or after MRI.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study parameters -Study parameters are the difference in detection performance,<br /><br>reproducibility and inter-observer agreement of ABVS compared to MRI and<br /><br>hand-held US. -Detection performance is measured by detection rate,<br /><br>sensitivity, specificity, positive and negative predictive values, and area<br /><br>under the ROC based on BIRADS scores.<br /><br>Amnedement: analysis of the false positive rate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a. (see primairy study parameters)</p><br>