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

Primary Purpose

Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-fluoro-dihydroxyphenylalanine
Positron emission tomography (PET)
Computed tomography (CT)
Magnetic resonance imaging
Sponsored by
Erik Mittra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Anaplastic Ependymoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2014
Last Updated
January 30, 2017
Sponsor
Erik Mittra
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02175745
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Re-evaluate indication with the referring physicians
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erik Mittra
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (FDOPA-PET/CT or PET/MRI)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
18F-fluoro-dihydroxyphenylalanine
Other Intervention Name(s)
(18)F-FDOPA, 18F-6-L-fluorodopa, 18F-DOPA, 18F-FDOPA, Fluorine F-18 fluorodopa
Intervention Description
Administered intravenously (IV)
Intervention Type
Procedure
Intervention Name(s)
Positron emission tomography (PET)
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Component of an 18F-FDOPA PET/CT or PET/MRI scan
Intervention Type
Procedure
Intervention Name(s)
Computed tomography (CT)
Other Intervention Name(s)
tomography, computed, CT scan
Intervention Description
Component of an 18F-FDOPA PET/CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance imaging
Other Intervention Name(s)
MRI scan, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Component of an 18F-FDOPA PET/MRI
Primary Outcome Measure Information:
Title
Number of Suspicious Lesions Identified by 18F FDOPA PET
Description
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.
Time Frame
Up to 30 minutes after injection of F18 FDOPA
Title
Percent Agreement of 18F FDOPA PET With Pathology
Description
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.
Time Frame
Up to 30 minutes post-injection (at time of scan)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Mittra, MD, PhD
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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