Imaging the response of glioblastoma brain tumours to treatment with radiotherapy and chemotherapy by magnetic resonance and positron emission tomography.
- Conditions
- brain cancerbrain tumours10029211
- Registration Number
- NL-OMON31106
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Suspected intracranial glioblastoma on MRI eligible for operation
Contrast enhancement after gadolineum on T1-weighted MRI
Eligible for additional treatment with radiotherapy and chemotherapy after the operation
Informed consent
Adult, patients
Exclusion Criteria
Karnovsky score < 70
Exclusioncriteria for MRI (eg known gadolinium allergy, pacemaker, neurostimulator, insulinepomp, defibrillator)
Patients with a post-operative proven non glioblastoma
Patients with a pre-operative non-enhancing FLT-PET scan
Pregnancy
Age > 70 years
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patients will be followed during the standard treatment.<br /><br>Before the neurosurgical operation, before and after the radiotherapy with<br /><br>concomitant chemotherapy, before the additive chemotherapy and after 2, 4 and 6<br /><br>cycles of chemotherapy a MRI, MRS and FLT-PET scan will be made.<br /><br>The operation, radiotherapy and chemotherapy will not be postponed for the<br /><br>scans. After the operation a MRI scan is made within 72 hours.<br /><br>The response to therapy will be measured in progression free period,<br /><br>conventional radiological response and clinical response and be compared to the<br /><br>results of MRS and FLT-PET.<br /><br>After the normal treatment the FLT-PET and MRS scans will continued together<br /><br>with normal follow up MRI scan depending on the results of the first 40 weeks.<br /><br>Normally every 3 months.<br /><br>The endpoint for the study is defined as the last patients last visit.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In the MR diagnostics protocol also diffusion- and perfusion weighted images<br /><br>are included. Changes in these images during the treatment will be correlated<br /><br>to the response of the tumour and compared to the results of the MRI, MRS and<br /><br>PET.<br /><br>Before the start of the additive chemotherapy the patients will be asked to<br /><br>answer questions about the burden and convenience of the study.</p><br>