Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: Blue Earth Diagnostics, Inc; Dragon Master Foundation

Criteria

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.