Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

21-019390

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

2024-07-01

2025-09-01

2026-09-01

Not yet recruiting

Early phase I

30

Inclusion Criteria: * LGG (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance * Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor) * Scheduled to receive systemic therapy * Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Age between ≥ 1 years but ≤21 years at time of study registration Exclusion Criteria: * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician * Pregnant participants * Patient who would require sedation or anesthesia for imaging beyond standard of care (SOC). * Participants who weigh less than 8 kg. * Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. * Participants with a history of abnormal kidney function or creatinine above expected values for age and gender. * Participants with primary tumors of the spinal cord.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-31