Clinical trial · Interventional
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
NCT03242824CI-TRIAL-00064675completedPhase 2Results postedClinicalTrials.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 proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine F 18 Fluorodopa | Drug | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DOPA PET
- description
- Patients will receive 18FDOPA-PET for radiation treatment planning
- interventionNames
- Drug: Fluorine F 18 Fluorodopa
- Radiation: Intensity-Modulated Radiation Therapy
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Proportion of Participants With Progression-free Survival
- timeFrame
- up to 3 months
- description
- measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls
Secondary outcomes (5)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age \> or equal to 18 years * ECOG PS \< or equal to 3 * Histologically confirmed or radiographic evidence of recurrent/progressive glioma. * History of radiation therapy to the brain for prior diagnosis of glioma * Planned radiation treatments at Mayo Clinic Rochester * Provide informed written consent * Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136 (blood draw optional) * Willing to return to enrolling institution for follow-up during Active Monitoring Phase of the study. Exclusion Criteria * More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to re-irradiation target volumes * Unable to undergo MRI scans with contrast * 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.