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Trial record 47 of 230 for:    "Anaplastic oligodendroglioma"

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

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ClinicalTrials.gov Identifier: NCT02175745
Recruitment Status : Terminated (Re-evaluate indication with the referring physicians)
First Posted : June 26, 2014
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Erik Mittra, Stanford University

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

Condition or disease Intervention/treatment Phase
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 Drug: 18F-fluoro-dihydroxyphenylalanine Procedure: Positron emission tomography (PET) Procedure: Computed tomography (CT) Procedure: Magnetic resonance imaging Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas
Study Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: 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.
Drug: 18F-fluoro-dihydroxyphenylalanine
Administered intravenously (IV)
Other Names:
  • (18)F-FDOPA
  • 18F-6-L-fluorodopa
  • 18F-DOPA
  • 18F-FDOPA
  • Fluorine F-18 fluorodopa

Procedure: Positron emission tomography (PET)
Component of an 18F-FDOPA PET/CT or PET/MRI scan
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Procedure: Computed tomography (CT)
Component of an 18F-FDOPA PET/CT
Other Names:
  • tomography, computed
  • CT scan

Procedure: Magnetic resonance imaging
Component of an 18F-FDOPA PET/MRI
Other Names:
  • MRI scan
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging




Primary Outcome Measures :
  1. Number of Suspicious Lesions Identified by 18F FDOPA PET [ Time Frame: Up to 30 minutes after injection of F18 FDOPA ]
    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.

  2. Percent Agreement of 18F FDOPA PET With Pathology [ Time Frame: Up to 30 minutes post-injection (at time of scan) ]
    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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175745


Locations
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Erik Mittra
National Cancer Institute (NCI)
Investigators
Principal Investigator: Erik Mittra, MD, PhD Stanford University Hospitals and Clinics

Responsible Party: Erik Mittra, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02175745     History of Changes
Other Study ID Numbers: IRB-29364
NCI-2014-01289 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRN0024 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2014    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Ependymoma
Gliosarcoma
Oligodendroglioma
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Eye Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs