This early phase I trial evaluates fluciclovine F18 (18F-fluciclovine) positron emission tomography-magnetic resonance imaging (PET-MRI) in differentiating tumor progression from post-treatment changes in pediatric and young adult patients with high 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 differentiate tumor progression from post-treatment changes in pediatric and young adult patients undergoing treatment for high grade gliomas.
Additional locations may be listed on ClinicalTrials.gov for NCT05553041.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Children's Hospital of PhiladelphiaStatus: Active
Contact: Seyed Ali Nabavizadeh
Phone: 215-450-7605
PRIMARY OBJECTIVES:
I. To evaluate 18F-fluciclovine PET uptake (maximum standardized uptake value [SUV max] and peak standardized uptake value [SUV peak]) as well as uptake kinetics post-radiation in pediatric participants with high grade glioma (HGG) and suspicion of progression versus pseudoprogression (PsP) after radiation and compare for differences in 18F-fluciclovine PET uptake between those subsequently confirmed with tumor progression versus (vs.) PsP based on 6-month clinical follow-up. (Cohort A)
II. To evaluate 18F-fluciclovine uptake in participants with tissue confirmed progressive HGG who undergo standard of care biopsy/resection for suspicion of progression in comparison to patient with tissue confirmed treatment-effect. (Cohort B)
SECONDARY OBJECTIVE:
I. To determine the safety profile of 8F-fluciclovine PET imaging in pediatric participants with HGG.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients receive 18F-fluciclovine intravenously (IV) and undergo PET-MRI approximately 4-6 weeks after completion of standard of care (SOC) radiation or within 4 weeks if there is suspicion for tumor progression (TP) or PsP on post-radiation MRI. Patients also undergo brain MRI during screening.
COHORT B: Patients receive18F-fluciclovine IV and undergo PET-MRI at time of suspected disease progression based on symptoms or SOC MRI within 4 weeks prior to planned SOC surgery. Patients also undergo brain MRI during screening.
After completion of study intervention, patients are followed for up to 6 months (cohort A) and at time of surgery (cohort B) through medical record review.
Lead OrganizationChildren's Hospital of Philadelphia
Principal InvestigatorSeyed Ali Nabavizadeh
