Clinical trial · Interventional
18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas
NCT02020720CI-TRIAL-00085024completedEarly 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)
This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Brain Neoplasm | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Diffusion Weighted Imaging | Procedure | — | UNRESOLVED |
| Fluorine F 18 Fluorodopa | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Perfusion Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-DOPA-PET)
- description
- 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.
- interventionNames
- Procedure: Biopsy
- Procedure: Computed Tomography
- Procedure: Diffusion Weighted Imaging
- Drug: Fluorine F 18 Fluorodopa
- Other: Laboratory Biomarker Analysis
- Procedure: Perfusion Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N
- timeFrame
- Up to 1 year
- description
- To determine the optimal PET threshold for distinguishing HGG from LGG brain tissue, receiver operating characteristic (ROC) analysis and the Youden's index (sum of the sensitivity and specificity - 1) will be used. The Youden's index will be calculated for each possible T/N threshold. The final ROC area under the curve (AUC) value and confidence intervals will be estimated using ROC analysis methods for clustered continuous data as described by Obychowski.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
Inclusion Criteria: * MRI findings compatible with newly diagnosed or recurrent 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 * 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 MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) * 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
References
Publications (0)
Data not yet available
No reference posted for this study.