Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Recruiting now · Early Phase 1
Conditions studied: Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial
In brief
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.
Key facts
- Study ID
- NCT05555550
- Run by
- Children's Hospital of Philadelphia
- People needed
- 30
- Starts
- 2026-07-29
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-04-29
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
- Participants must have evaluable disease (1x1 cm tumor on MRI)
- Scheduled to receive systemic therapy for LGG
- 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: Participants must be ≥ 1 years but ≤21 years of age at registration
- Being on a treatment regimen does not exclude a subject from enrollment.
You may not qualify if…
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Pregnant participants
- 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.
Where it is running
- The Children s Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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