Overview
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.
Eligibility
Inclusion Criteria:
- LGG including the brainstem and supratentorial only , (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 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 >= CTCAE v5.0 grade 2 at time of study registration.
- Participants with primary tumors of the spinal cord.