Clinical trial NCT02175745: 18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas
Official title: 18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-26
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Suspicious Lesions Identified by 18F FDOPA PET
timeFrame: Up to 30 minutes after injection of F18 FDOPA
measure: Percent Agreement of 18F FDOPA PET With Pathology
timeFrame: Up to 30 minutes post-injection (at time of scan)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Erik Mittra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: