A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

Mayo Clinic

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Malignant Glioma

Treatments: Drug: Fluorine-18-L-dihydroxyphenylalanine

Study type: Observational

Funder types: Other

Identifiers

NCT02104310

11-002165

Details and patient eligibility

About

For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.

Enrollment: 25 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥7 years.
• Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
• CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
• Willing to sign release of information for any follow-up records.
• Provide informed written consent.

Exclusion criteria

• Patients diagnosed with WHO grade IV malignant glioma.
• Patients previously treated with radiation therapy.
• Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
• 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)
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception

Trial design

25 participants in 1 patient group

Fluorine-18-L-dihydroxyphenylalanine

Description:

18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure

Treatment:

Drug: Fluorine-18-L-dihydroxyphenylalanine