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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Glioma

Treatments: Radiation: Intensity-Modulated Radiation Therapy; Procedure: Positron Emission Tomography; Drug: Fluorine F 18 Fluorodopa

Study type: Interventional

Funder types: Other

Identifiers

NCT03242824

MC167B (Other Identifier)

NCI-2017-02479 (Other Identifier)

16-006072

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

18F-DOPA PET

Experimental group

Description:

Patients will receive 18FDOPA-PET for radiation treatment planning

Treatment:

Drug: Fluorine F 18 Fluorodopa

Procedure: Positron Emission Tomography

Radiation: Intensity-Modulated Radiation Therapy