Detection of recurrent head and neck tumours after chemoradiation with a tumor-sensitive MRI technique.
Recruiting
- Conditions
- squamous cell carcinoma, recurrence, radiotherapyplaveiselcelcarcinoom, recidief, radiotherapie
- Registration Number
- NL-OMON29514
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU), Department if ENT
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
1. Patients with a oropharyngeal, hypopharyngeal, or laryngeal squamous cell carcinoma treated with (chemo)radiation with curative intent;
2. A clinical suspicion of a recurrence;
Exclusion Criteria
1. Patients with contraindication for MRI or contrast agent;
2. Patients who received salvage surgery for the primary lesion;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The diagnostic performance of DW-MRI for the detection of recurrence in patients with clinical suspicion of recurrent or persistent HNSCC after initial (chemo) radiation will be primarily reflected by the PPV of DW-MRI. Furthermore, the NPV, discrimination, sensitivity and specificity will be assessed.
- Secondary Outcome Measures
Name Time Method 1. Number of futile biopsies with DW-MRI as selection strategy for endoscopy with taking of biopsies;<br /><br>2. Discordant pairs (Regular imaging vs. DW-MRI);<br /><br>3. Number of missed cases by DW-MRI compared to regular imaging;<br /><br>4. Number of extra cases detected by DW-MRI compared to regular imaging.