Pilot study on the determination of therapy resistant areas within the tumor in patients with high-grade glioma by repeated 18F-FDG-PET-CT scans.

Completed

Conditions: high grade glioma
10029211

Registration Number: NL-OMON31444

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

•Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis
•WhO PFS <= 2
•Tumours which do enhance on pre-operative imaging.
•Post-operative enough visible residual tumour on PET or status after biopsy only
•Age >18 years
•Availability of deep fresh frozen tissue for molecular biologic evaluation - if possible
•Patient able to tolerate full course of conventional RT and follow serial scanning
•No previous radiotherapy to the head and neck and brain area.
•Prior neurosurgery within 6 weeks of treatment
•No previous chemotherapy before treatment of the glioma. Standard radiochemotherapy with temozolomide is not excluded
•No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed.
•No incapacitated patients.

Exclusion Criteria

No Histologically confirmed gliomas II - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
WHO PFS >2
Tumours which do not enhance on pre-operative imaging.
Post-operative not enough visible resiudal tumor on PET or status after biopsy only
Age < 18 years
Patient is not able to tolerate full course of conventional RT and follow serial scanning
Previous radiotherapy to the head and neck and brain area.
Prior neurosurgery not within 6 weeks of treatment
Previous chemotherapy before treatment of the glioma.
Prior or concurrent medical condition which would make treatment difficult to complete.
Incapacitated patients.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The end-point is the prediction of the localisation of the persistent tumour<br /><br>cells with remaining FDG-uptake -at the end of radiotherapy compared to the<br /><br>baseline PET and PET during radiotherapy,- as a function of the FDG-uptake<br /><br>dynamics during radiotherapy. </p><br>

Secondary Outcome Measures