Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study

Study Overview
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Brief Summary
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The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.

Official Title
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A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection

Conditions
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Cancer (High-grace Glioma)

Intervention / Treatment
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* Procedure: Surgical neuronavigation with 18F-DOPA PET imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma Karnofsky Performance status (KPS) ≥ 70 Age ≥18 years Subject is able to understand and consent to study Glomerular filtration rate (GFR) ≥ 45 ml/minute Exclusion Criteria: Indication for urgent craniotomy to relieve mass effect Only stereotactic biopsy indicated because tumour is located in eloquent brain. The enhancement on the T1 MRI sequence involves or abuts the basal ganglia Previous intracranial malignancy or any invasive malignancy unless free of disease > 5 years Prior cranial irradiation Contra-indications to systemic radiation exposure: pregnancy or breast feeding Subject exceeds the weight limit of the PET scanner bed (204.5 kg) Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease Allergies or other contraindication to CT contrast or MRI contrast

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DOPA PET imaging<br>Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection. | Procedure: Surgical neuronavigation with 18F-DOPA PET imaging<br>* Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan. |  | Less than 72 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurosurgery, Neuronavigation, Positron emission tomography, FDOPA