This phase II trial investigates [18F]DPA-714 PET in imaging brain neuroinflammation after whole brain radiation therapy in children with medulloblastoma. Inflammation of the brain, which is also known as neuroinflammation, plays an orchestrating role in brain injury after radiation therapy. [18F]DPA-714 is a radioactive PET tracer that binds to a specific protein called TSPO, allowing it to be detected during PET scan. The brain makes TPSO in excess if there is an inflammatory reaction, which can occur after radiation therapy. Monitoring TSPO over time may help researchers determine when and where in the brain neuroinflammatory changes are occurring after radiation therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05128903.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Temporarily closed to accrual
Contact: Asim Bag
Phone: 901-595-3300
PRIMARY OBJECTIVES:
I. Assessment of temporal and regional variability of uptake of translocator protein (TSPO) positron emission tomography (PET) tracer.
II. Correlation of radiation dose in specific brain regions with radiation induced neuroinflammation as measured by uptake of TSPO PET tracer.
EXPLORATORY OBJECTIVES:
I. Assessment of radiation-induced brain microstructure injuries (RIBMI) in specific brain regions (medial temporal lobe, frontal lobe, and in white matter) using advanced magnetic resonance imaging (MRI) techniques.
II. Association of radiation dose with MRI measures of RIBMI in these specific brain regions.
III. Association of PET measures of radiation induced neuroinflammation (RIN) with MRI measures of RIBMI.
IV. Association of PET measure of RIN and MRI measures of RIBMI in specific regions of interest (ROI) with specific domain of neuro-cognition.
V. Association of a novel MRI based technique for assessment of RIN with TSPO PET.
VI. Association of the PET and MRI measure of neuroinflammation within 2-years of completion of radiation with delayed cognitive outcome that will be measured at 3, 4 and 5 years from the completion of radiation therapy.
OUTLINE:
Patients receive fluorine F 18 DPA-714 ([18F]DPA-714) intravenously (IV) and undergo PET scan over 2 hours at baseline (before or within 2 weeks of start of radiation therapy), between 7 and 13 weeks after completion of radiation therapy before start of chemotherapy, 1 year from start of radiation therapy, and 1.5-2 years from start of radiation therapy. Patients also undergo MRI throughout the study.
After completion of intervention, patients are followed up 1-2 days after each scan, and annually for 10 years from radiation.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorAsim Bag
