No registrations found.
ID
Source
Brief title
Health condition
squamous cell carcinoma, recurrence, radiotherapy
plaveiselcelcarcinoom, recidief, radiotherapie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
1. 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.
Background summary
This study will investigate the accuracy of DW-MRI in detection of recurrent oropharyngeal, hypopharyngeal and laryngeal squamous cell carcinoma after (chemo)radiation.
Study objective
Diffusion Weighted MRI is an accurate imaging technique for detection of recurrent head and neck squamous cell carcinomas after (chemo)radiation therapy.
Study design
T0 = When there is a clinical suspicion of a recurrence;
T1 = 6 months post DW-MRI.
Intervention
One additional Diffusion Weighted MRI added to the regular imaging of choice.
Dept. of Otolaryngology
Room G05.129
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 566 44
W.Grolman@umcutrecht.nl
Dept. of Otolaryngology
Room G05.129
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 566 44
W.Grolman@umcutrecht.nl
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;
3. Last radiotherapy: > 2 months and < 3 years ago;
4. ‘Informed consent’ signed by patient;
5. Age ≥ 18 years.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3024 |
| NTR-old | NTR3172 |
| CCMO | NL37889.041.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35371 |