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NCT02175745 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2017-03-20

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Suspicious Lesions Identified by 18F FDOPA PET

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outcome · POSTED

Percent Agreement of 18F FDOPA PET With Pathology

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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 Names
    1. Drug: 18F-fluoro-dihydroxyphenylalanine
    2. Procedure: Positron emission tomography (PET)
    3. Procedure: Computed tomography (CT)
    4. Procedure: Magnetic resonance imaging
    label
    Diagnostic (FDOPA-PET/CT or PET/MRI)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Diagnostic (FDOPA-PET/CT or PET/MRI)
    description
    Administered intravenously (IV)
    name
    18F-fluoro-dihydroxyphenylalanine
    other Names
    1. (18)F-FDOPA
    2. 18F-6-L-fluorodopa
    3. 18F-DOPA
    4. 18F-FDOPA
    5. Fluorine F-18 fluorodopa
    type
    DRUG
  2. arm Group Labels
    1. Diagnostic (FDOPA-PET/CT or PET/MRI)
    description
    Component of an 18F-FDOPA PET/CT or PET/MRI scan
    name
    Positron emission tomography (PET)
    other Names
    1. FDG-PET
    2. PET
    3. PET scan
    4. tomography, emission computed
    type
    PROCEDURE
  3. arm Group Labels
    1. Diagnostic (FDOPA-PET/CT or PET/MRI)
    description
    Component of an 18F-FDOPA PET/CT
    name
    Computed tomography (CT)
    other Names
    1. tomography, computed
    2. CT scan
    type
    PROCEDURE
  4. arm Group Labels
    1. Diagnostic (FDOPA-PET/CT or PET/MRI)
    description
    Component of an 18F-FDOPA PET/MRI
    name
    Magnetic resonance imaging
    other Names
    1. MRI scan
    2. NMR imaging
    3. NMRI
    4. nuclear magnetic resonance imaging
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
DIAGNOSTIC
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Number of Suspicious Lesions Identified by 18F FDOPA PET
    time Frame
    Up to 30 minutes after injection of F18 FDOPA
  2. 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.
    measure
    Percent Agreement of 18F FDOPA PET With Pathology
    time Frame
    Up to 30 minutes post-injection (at time of scan)
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      primary nct id
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      source kind
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-b42d5a136e52e3b8e142
      link basis
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT02175745
        start
        0
      offset unit
      unicode_code_points
      query cond
      Pilocytic Astrocytoma
      query disease state id
      ds-pilocytic-astrocytoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pilocytic-astrocytoma-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c60b9ec3f416e0ab0533dfb0d89c7d8cb0105c140aa9a9385e6affa65f310473

    Preserved source evidence · Not medical advice