18F-DOPA-PET in Planning Surgery in Patients With Gliomas
NCT ID: NCT02020720
Last Updated: 2025-01-23
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
72 participants
INTERVENTIONAL
2014-01-22
2024-01-10
Brief Summary
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Detailed Description
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I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).
SECONDARY OBJECTIVES:
I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.
II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.
III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.
IV. Assess the time to progression for patients receiving resections and biopsies only.
TERTIARY OBJECTIVES:
I. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.
II. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.
III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.
OUTLINE:
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
After completion of study treatment, patients are followed up yearly 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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Diagnostic (18F-DOPA-PET)
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Biopsy
Undergo image-guided biopsy
Computed Tomography
Undergo 18F-DOPA-PET/CT
Diffusion Weighted Imaging
Undergo DTI
Fluorine F 18 Fluorodopa
Undergo 18F-DOPA-PET/CT
Laboratory Biomarker Analysis
Correlative studies
Perfusion Magnetic Resonance Imaging
Undergo pMRI
Positron Emission Tomography
Undergo 18F-DOPA-PET/CT
Therapeutic Conventional Surgery
Undergo stereotactic craniotomy
Interventions
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Biopsy
Undergo image-guided biopsy
Computed Tomography
Undergo 18F-DOPA-PET/CT
Diffusion Weighted Imaging
Undergo DTI
Fluorine F 18 Fluorodopa
Undergo 18F-DOPA-PET/CT
Laboratory Biomarker Analysis
Correlative studies
Perfusion Magnetic Resonance Imaging
Undergo pMRI
Positron Emission Tomography
Undergo 18F-DOPA-PET/CT
Therapeutic Conventional Surgery
Undergo stereotactic craniotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned craniotomy and resection or biopsy
* Willing to sign release of information for any radiation and/or follow-up records
* Provide informed written consent if \>= 18 years; if \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent
* Ability to provide tissue for mandatory correlative research component
Exclusion Criteria
* Unable to undergo an 18F-DOPA 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; NOTE: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
7 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Nadia N. Laack, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Debra H. Brinkmann, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
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-2013-02373
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1373
Identifier Type: OTHER
Identifier Source: secondary_id
13-005102
Identifier Type: OTHER
Identifier Source: secondary_id
MC1373
Identifier Type: -
Identifier Source: org_study_id
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