MR Imaging of Lymphadenopathy in Rectal Cancer using the MR Agent Vasovist
Phase 2
Suspended
- Conditions
- bowel cancerrectal cancer10017991
- Registration Number
- NL-OMON31454
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
Biopsy-proven rectal cancer
Age: at least 18 years
Surgery for rectal cancer planned within 60 days after Vasovist-enhanced MRI
Willing and able to undergo all study procedures
Written informed consent
Exclusion Criteria
Age < 18 years
Pregnant and/or nursing women
Contra-indication for MRI
Previous severe allergic reaction to MR-contrast agent
Allergy to any of the ingredients of VAsovist
History of previous malignancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Sensitivity, specificity, NPV and PPV of Vasovist®-enhanced MRI for detection<br /><br>lymph nodes with tumor infiltration (node-by node analysis)</p><br>
- Secondary Outcome Measures
Name Time Method <p>na</p><br>