Phase 2
N=20
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT03242824 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Proportion of Participants With Progression-free Survival — 0.85 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluorine F 18 Fluorodopa (Drug); Intensity-Modulated Radiation Therapy (Radiation); Positron Emission Tomography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Progression-free Survival |
0.85 | — |
| SECONDARY Overall Survival |
3.7 | — |
| SECONDARY Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities |
40 | — |
| SECONDARY Quality of Life Brief Fatigue Index (BFI) Change From Baseline |
0.28 | — |
| SECONDARY Re-operative Count |
— | — |
| SECONDARY Quality of Life MDASI-BT Change From Baseline |
-0.15 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03242824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.