Clinical trial · Interventional
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
A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors
NCT01165632CI-TRIAL-00094367completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. 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
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Ependymoma | Adult Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Brain Stem Glioma | Adult Brain Stem Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Ependymoma | Adult Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| fluorine F 18 fluorodopa | Drug | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| radiation therapy treatment planning/simulation | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Procedure: biopsy
- Procedure: computed tomography
- Procedure: therapeutic conventional surgery
- Radiation: radiation therapy treatment planning/simulation
- Radiation: radiation therapy
- Procedure: magnetic resonance imaging
- Procedure: positron emission tomography
- Drug: fluorine F 18 fluorodopa
Primary outcomes (2)
- measure
- 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
- timeFrame
- Up to 2 years
- description
- Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * 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 MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) * 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
References
Publications (0)
Data not yet available
No reference posted for this study.