Evaluating a new imaging method for low-grade brain tumors in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and effectiveness of 18F-Fluciclovine Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) in managing low-grade gliomas (LGG) in children. Participants will undergo imaging with 18F-Fluciclovine PET-MRI before starting therapy, and again at three months and one year after treatment initiation. The study will compare changes in 18F-Fluciclovine uptake with MRI measurements to evaluate the imaging method's utility in monitoring tumor response. The goal is to improve the management of LGG in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.
2. Participants must have evaluable disease (1x1 cm tumor on MRI)
3. Scheduled to receive systemic therapy for LGG
4. 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.
5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration
6. Being on a treatment regimen does not exclude a subject from enrollment.

Exclusion Criteria

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
2. Pregnant participants
3. Participants who weigh less than 8 kg.
4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
5. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
6. Participants with primary tumors of the spinal cord.

Where it's running

• The Children s Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Mariam Aboian, MD,PhD — The Children s Hospital of Philadelphia
• Study coordinator: Mariam Aboian, MD, PhD
• Email: aboianm@chop.edu
• Phone: 215-510-7661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.