RecruitingEarly Phase 1NCT05555550

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

Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)


Sponsor

Children's Hospital of Philadelphia

Enrollment

30 participants

Start Date

Jul 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized PET-MRI scan with a tracer called 18F-Fluciclovine to better monitor low-grade brain tumors (LGG) in children and young adults receiving treatment. The goal is to get clearer pictures of how these tumors respond over time. **You may be eligible if:** - You are between 1 and 21 years old - You have a confirmed or suspected low-grade brain tumor (WHO grade I or II) - Your tumor measures at least 1 cm x 1 cm on MRI - You are scheduled to receive treatment for your brain tumor - You are reasonably mobile and functional (Karnofsky or Lansky score of 50 or higher) **You may NOT be eligible if:** - You are pregnant - You weigh less than 8 kg (about 17 lbs) - You cannot avoid contact with a pregnant woman or infant for 12 hours after the scan - You have kidney problems - Your tumor is located in the spinal cord Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-Fluciclovine

18F-Fluciclovine will be injected via IV prior to PET-MRI imaging


Locations(1)

The Children s Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT05555550


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