Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma
NCT ID: NCT01165632
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
24 participants
INTERVENTIONAL
2010-07-26
2019-07-26
Brief Summary
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PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
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Detailed Description
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I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE:
Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
After completion of study treatment, patients are followed up every year for 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm I
Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
biopsy
Correlative studies
computed tomography
Undergo computed tomography
therapeutic conventional surgery
Undergo stereotactic craniotomy
radiation therapy treatment planning/simulation
Undergo radiation therapy treatment planning/simulation
radiation therapy
Undergo radiation therapy
magnetic resonance imaging
Undergo magnetic resonance imaging
positron emission tomography
Undergo positron emission tomography
fluorine F 18 fluorodopa
Given IV
Interventions
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biopsy
Correlative studies
computed tomography
Undergo computed tomography
therapeutic conventional surgery
Undergo stereotactic craniotomy
radiation therapy treatment planning/simulation
Undergo radiation therapy treatment planning/simulation
radiation therapy
Undergo radiation therapy
magnetic resonance imaging
Undergo magnetic resonance imaging
positron emission tomography
Undergo positron emission tomography
fluorine F 18 fluorodopa
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
* Planned craniotomy and resection or biopsy
* Willing to sign release of information for any radiation and/or follow-up records
* Negative pregnancy test done =\< 48 hours of injection of study drug, for women of childbearing potential only
* Provide informed written consent
* Patients with eGFR \< 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.
Exclusion Criteria
* Unable to undergo an 18F-FDOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
* Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Nadia N. Laack, M.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2010-01607
Identifier Type: REGISTRY
Identifier Source: secondary_id
10-001904
Identifier Type: OTHER
Identifier Source: secondary_id
MC1078
Identifier Type: OTHER
Identifier Source: secondary_id
MC1078
Identifier Type: -
Identifier Source: org_study_id
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