mri

Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme - a randomised phase II trial

This study is designed to test if a radiotherapy target volume delineation based on Amino-acid PET (AA-PET) leads to an improvement in progression free survival in patients with recurrent GBM treated with re-irradiation, compared to target volume delineation based on Gadolinium contrast enhanced T1 weighted Magnetic Resonance Imaging (T1Gd-MRI).

Inclusion criteria

• Local recurrence of GBM (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of recurrent GBM
• Histological confirmation of GBM at initial or secondary diagnosis
• Previous radiation therapy of the primary with a maximal total dose 59-60 Gy
• At least 6 months since the end of pre-irradiation
• Recurrent tumor visible on AA-PET and T1Gd-MRI with the diameter measuring 1cm to 6cm by either technique
• Target volume definition possible according to both study arms
• Start of re-irradiation possible within 2 weeks from FET-PET and MRI
• Patient's written IC obtained on the day of FET-PET acquisition or latest the day after FET-PET acquisition
• Legal capacity
• Karnofsky Performance Score (KPS) > 60%
• Age ≥18 years (no upper limit of age)
• Registration

Exclusion criteria

• No histological confirmation of GBM
• Recent (≤4 weeks before IC) histological result showing no tumor recurrence
• No prior radiation treatment to the primary tumor
• More than 2 previous chemotherapy regimes or previous treatment with Avastin or other molecular targeted therapies
• Technical impossibility to use MRI or FET-PET for Radiation Therapy (RT)-planning
• Less than 2 weeks between application of chemotherapy and planned start of re-irradiation
• Less than 3 weeks between resection of recurrent GBM and planned start of re-irradiation
• Chemotherapy or molecular targeted therapies planned during re-irradiation
• Additional chemotherapy or molecular targeted therapy or further surgery planned before diagnosis of further tumor progression after study intervention
• Female patients of childbearing potential who are pregnant or breast feeding
• Fertile patients refusing to use safe contraceptive methods during the study
• Known allergy against the MRI contrast agent Gadolinium or the PET tracer 18F FET or against any of the components