Validation of diffusion weighted MR images of laryngeal cancer with histopathology
Completed
- Conditions
- laryngeal cancerLaryngeal carcinoma10027655
- Registration Number
- NL-OMON55866
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Patients with a T3 or T4 laryngeal or hypopharyngeal cancer scheduled for
total laryngectomy.
- Age >= 18 years.
- Informed consent.
Exclusion Criteria
- Patients with indications for primary radiotherapy.
- Patients with contraindications for surgery.
- Patients who meet exclusion criteria for MRI at 3T as defined in the
protocols of the Radiology department.
- Patients with contraindication for CT contrast administration as defined in
the protocols of the Radiology department.
- Patients with insulin dependent diabetes mellitus.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The accuracy of DW-MRI in determining the volume of the tumour.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The sensitivity (part of the tumour that is delineated) and positive predictive<br /><br>power (part of the delineated volume that is tumour) of DW-MRI based tumour<br /><br>delineation compared with values obtained using CT, PET and anatomical MR<br /><br>imaging.<br /><br><br /><br>The microscopic extension of the tumour measured as the distance between the<br /><br>gross tumour volume and the most distant microscopic lesions in the<br /><br>histopathology.</p><br>