Phase 2 Completed N=20 Treatment

The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma

Glioma

Source: ClinicalTrials.gov NCT03242824 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcomePrimary: Proportion of Participants With Progression-free Survival — 0.85 Proportion of participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.