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 range

1 Year – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is listed as an Early Phase 1 trial using a radioactive imaging agent called 18F-Fluciclovine — since it's such an early phase, what do we actually know so far about how safe this tracer is in children specifically?
2I understand the trial is comparing PET scans using 18F-Fluciclovine with standard MRI scans before my child starts systemic treatment — does participating in this imaging study change or delay any of the actual treatment decisions we'd be making?
3Since the trial is measuring something called 'standardized uptake value' on the PET scans, can you explain in plain terms what researchers are hoping to learn, and how that information might or might not benefit my child directly versus helping future patients?
4My child would be having both a PET scan and an MRI — can you walk me through what the combined PET-MRI procedure involves, how long it takes, whether sedation is needed, and how many visits this would require on top of their regular treatment schedule?
5Before we consider this trial, would you recommend my child first complete standard-of-care imaging and treatment for their low-grade glioma, or does this study fit naturally alongside what you'd already be doing?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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