NCT02175745

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

June 24, 2014

Results QC Date

January 30, 2017

Last Update Submit

January 30, 2017

Conditions

Adult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Diffuse AstrocytomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Mixed GliomaAdult OligodendrogliomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult Subependymal Giant Cell AstrocytomaChildhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral AstrocytomaChildhood Low-grade Cerebellar AstrocytomaChildhood Low-grade Cerebral AstrocytomaRecurrent Adult Brain TumorRecurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood Diffuse AstrocytomaRecurrent Childhood Fibrillary AstrocytomaRecurrent Childhood Gemistocytic AstrocytomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood GliosarcomaRecurrent Childhood OligoastrocytomaRecurrent Childhood OligodendrogliomaRecurrent Childhood Pilomyxoid AstrocytomaRecurrent Childhood Protoplasmic AstrocytomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaUntreated Childhood Anaplastic AstrocytomaUntreated Childhood Anaplastic OligoastrocytomaUntreated Childhood Anaplastic OligodendrogliomaUntreated Childhood Brain Stem GliomaUntreated Childhood Cerebellar AstrocytomaUntreated Childhood Cerebral AstrocytomaUntreated Childhood Diffuse AstrocytomaUntreated Childhood Fibrillary AstrocytomaUntreated Childhood Gemistocytic AstrocytomaUntreated Childhood Giant Cell GlioblastomaUntreated Childhood GlioblastomaUntreated Childhood Gliomatosis CerebriUntreated Childhood GliosarcomaUntreated Childhood OligoastrocytomaUntreated Childhood OligodendrogliomaUntreated Childhood Pilomyxoid AstrocytomaUntreated Childhood Protoplasmic AstrocytomaUntreated Childhood Subependymal Giant Cell AstrocytomaUntreated Childhood Visual Pathway and Hypothalamic GliomaUntreated Childhood Visual Pathway Glioma

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

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

EXPERIMENTAL

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-dihydroxyphenylalanineProcedure: Positron emission tomography (PET)Procedure: Computed tomography (CT)Procedure: Magnetic resonance imaging

Interventions

18F-fluoro-dihydroxyphenylalanineDRUG

Administered intravenously (IV)

Also known as: (18)F-FDOPA, 18F-6-L-fluorodopa, 18F-DOPA, 18F-FDOPA, Fluorine F-18 fluorodopa
Diagnostic (FDOPA-PET/CT or PET/MRI)
Positron emission tomography (PET)PROCEDURE

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

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (FDOPA-PET/CT or PET/MRI)
Computed tomography (CT)PROCEDURE

Component of an 18F-FDOPA PET/CT

Also known as: tomography, computed, CT scan
Diagnostic (FDOPA-PET/CT or PET/MRI)
Magnetic resonance imagingPROCEDURE

Component of an 18F-FDOPA PET/MRI

Also known as: MRI scan, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (FDOPA-PET/CT or PET/MRI)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

EpendymomaOligodendrogliomaAstrocytomaGlioblastomaGliosarcomaGliomaBrain NeoplasmsNeoplasms, NeuroepithelialOptic Nerve Glioma

Interventions

fluorodopa F 18Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

This study was underpowered due to low enrollment

Results Point of Contact

Title
Erik Mittra, MD, PhD
Organization
Stanford University
emittra@stanford.edu
650-736-2859

Study Officials

  • Erik Mittra, MD, PhD

    Stanford University Hospitals and Clinics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

March 20, 2017

Results First Posted

March 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)