Using 18F-fluciclovine PET-MRI to assess high-grade gliomas 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 evaluates the safety and usefulness of 18F-fluciclovine PET imaging in managing pediatric patients with high-grade gliomas (HGG). The goal is to differentiate between true tumor progression and post-treatment changes that can mimic progression after radiation and immunotherapy. By utilizing this advanced imaging technique, researchers aim to improve clinical decision-making regarding treatment options for these patients. The study focuses on children aged 1 to 21 years with histopathologically confirmed HGG or diffuse midline glioma.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 1\. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \>=2/3 of the pons).
* 2\. Measurable disease, measuring at least 1x1 cm.
* 3\. Life expectancy of greater than 8 weeks.
* 4\. Age \> 1 years but \< 21 years of age at enrollment.

For those without planned surgery:

* 1\. Participants with clinical and/or radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan.

or

* 2\. Participants with suspicion for TP or PsP on first post-radiation MRI

For those with planned surgery:

* 1\. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.

Exclusion Criteria:

* 1\. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
* 2\. Pregnant or breastfeeding participants.
* 3\. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).
* 4\. Participants who weigh less than 8 kg.
* 5\. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
* 6\. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.

  7\. Participants with primary tumors of the spinal cord.

Where it's running

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

Study contacts

• Principal investigator: Mariam Aboian, MD,PhD — 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.