This early phase I trial evaluates 18F-fluciclovine positron emission tomography-magnetic resonance imaging (PET-MRI) as a biomarker of response in pediatric and young adult patients with low grade gliomas. 18F-fluciclovine is a synthetic amino acid used as a PET radioactive tracer to detect disease. A PET scan is a procedure in which a small amount of radioactive tracer, like 18F-fluciclovine, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells can often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The technique is valuable for the diagnosis of many pathologic conditions, including cancer. PET-MRI scans are hybrid scanners that combine both modalities into a single scan during the same examination. Using the radioactive tracer, 18F-fluciclovine, with PET-MRI may be a useful and safe diagnostic tool to determine response in pediatric and young adult patients undergoing treatment for low grade gliomas.
Additional locations may be listed on ClinicalTrials.gov for NCT05555550.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Children's Hospital of PhiladelphiaStatus: Active
Contact: Seyed Ali Nabavizadeh
Phone: 215-450-7605
PRIMARY OBJECTIVE:
I. To compare the relative and absolute changes of tumor maximum standard uptake value (SUVmax), peak standard uptake value (SUVpeak) and metabolic tumor volume in fluciclovine F18 (18F-fluciclovine) PET and tumor measurements on MRI at 3 months and 1 year and as compared to pretreatment baseline imaging in pediatric participants who initiate systemic treatment for low grade gliomas (LGG).
SECONDARY OBJECTIVE:
I. To determine the safety profile of 18F-fluciclovine PET in pediatric LGG participants.
EXPLORATORY OBJECTIVES:
I. To determine if baseline 18F-fluciclovine PET uptake is predictive of likelihood of response to systemic therapy.
II. To compare the relative and absolute changes of tumor SUVmax, SUVpeak and metabolic tumor volume in 18F-fluciclovine PET at the time of progression and compare to previous PET and MRI measurements.
OUTLINE:
Patients receive 18F-fluciclovine intravenously (IV) and undergo PET-MRI within 28 days prior to starting treatment (baseline) and then at 3 months and 1 year after starting treatment or at the time of progression if earlier. Patients also undergo brain MRI at screening.
After completion of study intervention, patients are followed up through medical record review for up to 1 year.
Lead OrganizationChildren's Hospital of Philadelphia
Principal InvestigatorSeyed Ali Nabavizadeh
