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

Erik Mittra

Status: Terminated

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

Treatments: Procedure: Magnetic resonance imaging; Procedure: Positron emission tomography (PET); Drug: 18F-fluoro-dihydroxyphenylalanine; Procedure: Computed tomography (CT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02175745

NCI-2014-01289 (Registry Identifier)

IRB-29364

P30CA124435 (U.S. NIH Grant/Contract)

BRN0024 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Computed tomography (CT)

Drug: 18F-fluoro-dihydroxyphenylalanine

Procedure: Magnetic resonance imaging

Procedure: Positron emission tomography (PET)