RecruitingEarly Phase 1

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

United States30 participantsStarted 2026-07-29

Plain-language 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.

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET

Timeframe: 1 year

Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG

Timeframe: 1 year

Trial details

NCT IDNCT05555550

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Mariam Aboian, MD, PhD

215-510-7661 aboianm@chop.edu

View on ClinicalTrials.gov More Glioma trials