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Detection of recurrent head and neck tumours after chemoradiation with a tumor-sensitive MRI technique.


- candidate number10609
- NTR NumberNTR3172
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2011
- Secondary IDsNL37889.041.11 CCMO
- Public TitleDetection of recurrent head and neck tumours after chemoradiation with a tumor-sensitive MRI technique.
- Scientific TitleDetection of recurrent head and neck squamous cell carcinomas with Diffusion Weighted MRI after (chemo)radiation.
- ACRONYMRETURNED
- hypothesisDiffusion Weighted MRI is an accurate imaging technique for detection of recurrent head and neck squamous cell carcinomas after (chemo)radiation therapy.
- Healt Condition(s) or Problem(s) studiedRadiotherapy, Squamous cell carcinoma (SCC), Relapse
- Inclusion criteria1. Patients with a oropharyngeal, hypopharyngeal, or laryngeal squamous cell carcinoma treated with (chemo)radiation with curative intent;
2. A clinical suspicion of a recurrence;
3. Last radiotherapy: > 2 months and < 3 years ago;
4. ‘Informed consent’ signed by patient;
5. Age ≥ 18 years.
- Exclusion criteria1. Patients with contraindication for MRI or contrast agent;
2. Patients who received salvage surgery for the primary lesion;
3. Patients whom recurrence is so obvious that no additional imaging confirmation is necessary for the decision to take biopsies.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate1-dec-2013
- Target number of participants75
- InterventionsOne additional Diffusion Weighted MRI added to the regular imaging of choice.
- Primary outcomeThe 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 outcome1. Number of futile biopsies with DW-MRI as selection strategy for endoscopy with taking of biopsies;
2. Discordant pairs (Regular imaging vs. DW-MRI);
3. Number of missed cases by DW-MRI compared to regular imaging;
4. Number of extra cases detected by DW-MRI compared to regular imaging.
- TimepointsT0 = When there is a clinical suspicion of a recurrence;
T1 = 6 months post DW-MRI.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W. Grolman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Grolman
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThis study will investigate the accuracy of DW-MRI in detection of recurrent oropharyngeal, hypopharyngeal and laryngeal squamous cell carcinoma after (chemo)radiation.
- Main changes (audit trail)
- RECORD2-dec-2011 - 12-dec-2011


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