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

Mayo Clinic21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma

Interventions

Fluorine F 18 FluorodopaDRUG

Contrast used in PET

Intensity-Modulated Radiation TherapyRADIATION

Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor

Positron Emission TomographyPROCEDURE

imaging test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Proportion of Participants With Progression-free Survival

measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls

Time frame: up to 3 months

Secondary Outcomes

Overall Survival

Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization

Time frame: 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

Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)

Time frame: up to 2 years

Quality of Life Brief Fatigue Index (BFI) Change From Baseline

Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.

Time frame: Baseline and 3 months

Re-operative Count

Count of patients that receive re-operation post re-irradiation

Time frame: up to 2 years

Quality of Life MDASI-BT Change From Baseline

Data from ClinicalTrials.gov

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