This pilot phase II trial studies how well fluorine F 18 fluorodopa positron emission tomography (PET)/magnetic resonance imaging (MRI) or PET/computed tomography (CT) and radiation therapy work in treating patients with high-grade glioma that has come back (recurrent). Fluorine F 18 fluorodopa PET/MRI or PET/CT may give doctors a better idea of where the disease is that needs to be treated with radiation, rather than using MRI alone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03242824.
PRIMARY OBJECTIVE:
I. Compare the progression-free survival rate at 3 months for recurrent high-grade glioma patients after reirradiation targeting volumes designed with both fluorine F 18 fluorodopa (18F-DOPA)-PET and conventional MRI with historical controls.
SECONDARY OBJECTIVES:
I. Compare overall survival from reirradiation and overall survival from initial diagnosis with historical controls.
II. Prospectively evaluate toxicity and reoperation rates after reirradiation.
III. Prospectively evaluate quality of life and fatigue using patient reported outcomes.
CORRELATIVE RESEARCH OBJECTIVES:
I. Compare volume of 18F-DOPA-PET uptake with MRI contrast enhancement and T2 fluid-attenuated inversion recovery (FLAIR) for patients undergoing re-irradiation for recurrent high-grade glioma.
II. Evaluate patterns of failure after reirradiation in relation to pre-treatment MRI and 18F-DOPA-PET abnormalities.
OUTLINE:
Patients receive fluorine F 18 fluorodopa intravenously (IV) and undergo PET/CT or PET/MRI over 20 minutes. Patient undergoing PET/CT undergo a separate MRI no more than 14 days prior to beginning radiation treatments. Patients then undergo radiation therapy daily 5 days per week for 10 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2-3 months for 2 years.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorNadia Nicole Laack
