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18F-Fluciclovine PET-MRI for High-Grade Glioma in Children

This study is looking at how well a special imaging test, called 18F-fluciclovine (Axumin®) PET-MRI, works in children and young adults with high-grade glioma (a type of brain tumor). Doctors want to see if this imaging can help tell the difference between tumor growth and other changes that can happen after treatment. This is important because it helps doctors decide if treatment needs to change. You might be able to join if you are between 1 and 21 years old, have a high-grade glioma, and have measurable disease. The study aims to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 30 participants.
What's involved
You would receive an injection of 18F-fluciclovine (Axumin®) into your vein before having a PET-MRI scan. The study will analyze images at 6 months and tissue samples at 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will analyze images up to 6 months after the intervention and tissue samples up to 4 weeks after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05553041

18F-Fluciclovine PET-MRI in High-grade Glioma

Recruiting
EARLY_PHASE1Ages 1–21InterventionalDiagnostic
Children's Hospital of Philadelphia
~30 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:18F-Fluciclovine PET-MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Image analysis
Measured over 6 months
+1 more outcome measured

Conditions

Glioma
High Grade Glioma
Glioma, Malignant
Glioma Intracranial
Diffuse Glioma

Explore related trials

Diffuse Intrinsic Pontine GliomaDiffuse Midline GliomaMalignant Glioma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Mariam Aboian, MD,PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Mariam Aboian, MD, PhD
[email protected]
215-510-7661
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
2\. Participants with suspicion for TP or PsP on first post-radiation MRI
1\. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.

Exclusion

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.

What this trial measures

  • Image analysis6 months

    Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.

  • Histopathology analysis4 weeks

    Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.