Clinical trial NCT03242824: The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Official title: MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Proportion of Participants With Progression-free Survival
timeFrame: up to 3 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years
measure: Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities
timeFrame: up to 2 years
measure: Quality of Life Brief Fatigue Index (BFI) Change From Baseline
timeFrame: Baseline and 3 months
measure: Re-operative Count
timeFrame: up to 2 years
measure: Quality of Life MDASI-BT Change From Baseline
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nadia N Laack
role: PRINCIPAL_INVESTIGATOR
References: