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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

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.

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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.

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (FDOPA-PET/CT or PET/MRI)

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.

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type PROCEDURE

Component of an 18F-FDOPA PET/MRI

18F-fluoro-dihydroxyphenylalanine

Intervention Type DRUG

Administered intravenously (IV)

Positron emission tomography (PET)

Intervention Type PROCEDURE

Component of an 18F-FDOPA PET/CT or PET/MRI scan

Computed tomography (CT)

Intervention Type PROCEDURE

Component of an 18F-FDOPA PET/CT

Interventions

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Magnetic resonance imaging

Component of an 18F-FDOPA PET/MRI

Intervention Type PROCEDURE

18F-fluoro-dihydroxyphenylalanine

Administered intravenously (IV)

Intervention Type DRUG

Positron emission tomography (PET)

Component of an 18F-FDOPA PET/CT or PET/MRI scan

Intervention Type PROCEDURE

Computed tomography (CT)

Component of an 18F-FDOPA PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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(18)F-FDOPA 18F-6-L-fluorodopa 18F-DOPA 18F-FDOPA Fluorine F-18 fluorodopa FDG-PET PET PET scan tomography, emission computed tomography, computed CT scan MRI scan NMR imaging NMRI nuclear magnetic resonance imaging

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No