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The use diffusion measured by MRI in order to predict the effect of (chemo)radiotherapy in patients with cancer of the head and neck.


- candidate number25554
- NTR NumberNTR6136
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2016
- Secondary IDsNL57164.041.16 
- Public TitleThe use diffusion measured by MRI in order to predict the effect of (chemo)radiotherapy in patients with cancer of the head and neck.
- Scientific TitlePredictive value of diffusion weighted MRI in patients with HNSCC treated by (chemo)radiotherapy
- ACRONYMPREDICT
- hypothesisThe change in 'apparent diffusion coefficient' (ADC), obtained using diffusion weighted MRI, from pre-treatment to intra-treatment is lower in HNSCC patients with a poor response to (chemo)radiotherapy than in HNSCC patients with a good response to (chemo)radiotherapy.
- Healt Condition(s) or Problem(s) studiedHead and Neck Squamous Cell Carcinoma
- Inclusion criteria- Squamous cell carcinoma
- T2, T3 or T4 Oral cavity or pharynx
- T3 or T4 larynx
- Technically resectable
- Scheduled for primary (chemo)radiation with curative intent
- ‘Informed consent’ signed by patient
- Exclusion criteria- Age < 18 years
- Pregnancy
- Patients unsuited for MRI examination as defined in the protocols of the Radiology department.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2016
- planned closingdate1-dec-2018
- Target number of participants100
- InterventionsPatients meeting the inclusion criteria will be recruited from the department of head and neck surgical oncology. Pretreatment imaging consist of standard head and neck MRI sequences and added diffusion weighted sequence. Subsequently all patients will receive radiotherapy with or without concomitant chemotherapy following standard procedure. During the radiotherapy course additional MRI imaging including diffusion weighted sequences will be acquired in the study group. The scans will be planned for week 2, 3, 4 and 5 of the radiotherapy course.
- Primary outcomeThe primary endpoint is the predictive value of DW-MRI after the start of radiotherapy based on a single scan during treatment.
- Secondary outcome- ADC level and tumor volume pretreatment
- Change ADC level and gross tumor volume during therapy
- The optimal time point for MRI scanning during treatment in order to predict treatment outcome
- TimepointsFour additional MRI scans will be made in week 2, 3, 4 and 5 of the radiotherapy treatment. After finishing treatment study participants will receive 2 years of follow up as per standard post-treatment HNSCC protocol.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Boris Peltenburg
- CONTACT for SCIENTIFIC QUERIES Boris Peltenburg
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-nov-2016 - 3-jan-2017


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