A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

Study Overview
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Brief Summary
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For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.

Official Title
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A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients

Conditions
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Malignant Glioma

Intervention / Treatment
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* Drug: Fluorine-18-L-dihydroxyphenylalanine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥7 years. Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma. CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester. Willing to sign release of information for any follow-up records. Provide informed written consent. Exclusion Criteria: Patients diagnosed with WHO grade IV malignant glioma. Patients previously treated with radiation therapy. Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure). Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists) Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception

Ages Eligible for Study
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Minimum Age: 7 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluorine-18-L-dihydroxyphenylalanine<br>18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure | Drug: Fluorine-18-L-dihydroxyphenylalanine<br>* 5 millicuries ± 10%; Intravenous injection; 1 time<br>* Other names: FDOPA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment volume comparison | The primary endpoint for this pilot study will be to compare radiotherapy treatment volumes defined by conventional MR-only with treatment volumes defined with both 18F-DOPA PET and conventional MR information | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advanced imaging volume comparison | For patients who have advanced MRI scans performed as part of standard clinical care, advanced MRI volumes will be compared with conventional MRI volumes as well as 18F-DOPA PET volumes | 6 weeks | 
| Concordance with recurrence | For patients who progress radiographically within the observation period of this study will compare concordance of recurrence locations with pre-treatment 18F-DOPA PET uptake | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant glioma, FDOPA, PET CT, radiation therapy