FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy

Study Overview
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Brief Summary
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Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema. To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.

Official Title
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(18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy

Conditions
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Glioblastoma Multiforme, Anaplastic Astrocytoma, Radiotherapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years or older Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma Patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on MRI An MRI or a scan 48h after surgery should be available WHO ≤ 2 Indication for adjuvant radiotherapy Surgery must have been performed 45 days before the start of radiotherapy. Ability to understand and to give consent Exclusion Criteria: Age < 18 Years. Prior radiation therapy to the brain Any usual formal indication against MRI (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...) Allergic reaction to FET Pregnant women or nursing mothers Refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images | Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET. | Irradiation target volumes associated with standard MRI | 12 months | 
| Sites of failures with composite and standard MRI based RT planning | Irradiation target volumes associated with standard MRI based RT planning | 12 months | 
| Progression-free Survival |  | 12 months |