18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

Study Overview
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Brief Summary
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To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.

Detailed Description
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This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.

Official Title
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18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas

Conditions
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Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Low-grade Cerebellar Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Recurrent Adult Brain Tumor, Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Anaplastic Oligoastrocytoma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Diffuse Astrocytoma, Recurrent Childhood Fibrillary Astrocytoma, Recurrent Childhood Gemistocytic Astrocytoma, Recurrent Childhood Giant Cell Glioblastoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Gliomatosis Cerebri, Recurrent Childhood Gliosarcoma, Recurrent Childhood Oligoastrocytoma, Recurrent Childhood Oligodendroglioma, Recurrent Childhood Pilomyxoid Astrocytoma, Recurrent Childhood Protoplasmic Astrocytoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Untreated Childhood Anaplastic Astrocytoma, Untreated Childhood Anaplastic Oligoastrocytoma, Untreated Childhood Anaplastic Oligodendroglioma, Untreated Childhood Brain Stem Glioma, Untreated Childhood Cerebellar Astrocytoma, Untreated Childhood Cerebral Astrocytoma, Untreated Childhood Diffuse Astrocytoma, Untreated Childhood Fibrillary Astrocytoma, Untreated Childhood Gemistocytic Astrocytoma, Untreated Childhood Giant Cell Glioblastoma, Untreated Childhood Glioblastoma, Untreated Childhood Gliomatosis Cerebri, Untreated Childhood Gliosarcoma, Untreated Childhood Oligoastrocytoma, Untreated Childhood Oligodendroglioma, Untreated Childhood Pilomyxoid Astrocytoma, Untreated Childhood Protoplasmic Astrocytoma, Untreated Childhood Subependymal Giant Cell Astrocytoma, Untreated Childhood Visual Pathway and Hypothalamic Glioma, Untreated Childhood Visual Pathway Glioma

Intervention / Treatment
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* Drug: 18F-fluoro-dihydroxyphenylalanine
* Procedure: Positron emission tomography (PET)
* Procedure: Computed tomography (CT)
* Procedure: Magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 15 year-old at the time of radiotracer administration Provides written informed consent Suspected new diagnosis or suspected recurrence of glioma Able to remain still for duration of each imaging procedure (about 20 minutes) Exclusion Criteria: Less than 15 year-old at the time of radiotracer administra Unable to provide informed consent Inability to lie still for the entire imaging time Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Ages Eligible for Study
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Minimum Age: 16 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (FDOPA-PET/CT or PET/MRI)<br>Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later. | Drug: 18F-fluoro-dihydroxyphenylalanine<br>* Administered intravenously (IV)<br>* Other names: Fluorine F-18 fluorodopa;Procedure: Positron emission tomography (PET)<br>* Component of an 18F-FDOPA PET/CT or PET/MRI scan<br>* Other names: tomography, emission computed;Procedure: Computed tomography (CT)<br>* Component of an 18F-FDOPA PET/CT<br>* Other names: CT scan;Procedure: Magnetic resonance imaging<br>* Component of an 18F-FDOPA PET/MRI<br>* Other names: nuclear magnetic resonance imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Suspicious Lesions Identified by 18F FDOPA PET | The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician. | Up to 30 minutes after injection of F18 FDOPA | 
| Percent Agreement of 18F FDOPA PET With Pathology | For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated. | Up to 30 minutes post-injection (at time of scan) |