‘Saving the brain’
- Conditions
- Head-neck cancer
- Registration Number
- NL-OMON24435
- Lead Sponsor
- Medical Imaging Center, UMCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
?adults (18-70 years),
?referred for treatment of tumours located in nasopharynx, oropharynx and sinonasal cavity with radiotherapy (photons or protons), with or without systemic treatment, with a close proximity of 1.5 cm of the clinical target volume (CTV elective dose) to the brain or brainstem.
?age <18 or > 70 years old at baseline;
?brain neurological disease other than consequences of head and neck cancer and its treatment (like a stroke);
?history of psychiatric disease;
?history of chemotherapy or radiotherapy for other tumours;
?chronic treatment with verapamil at baseline;
?pregnancy;
?contradictions for performing MRI, such as non-MRI compatible heart pacemaker, metallic foreign body in the eye, aneurysm clip in the brain or claustrophobic patient;
?contrast allergies.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence, location and appearance of brain microvascular and white matter radiotherapy-induced changes on sequentially obtained MRI & PET images performed in several time points in comparison with the baseline MRI and PET images and conventional MRI images.
- Secondary Outcome Measures
Name Time Method Is there an association between the early brain damage demonstrated with MRI and PET imaging with the subsequent occurrence later brain damage on MRI and PET and cognitive and neurobehavioral changes in patients treated for head and neck tumours? <br>Have patients that received proton therapy less brain damage than patients with photon therapy?