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

Recruiting now · Early Phase 1

Conditions studied: Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma

In brief

The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

Key facts

Study ID

NCT05553041

Run by

Children's Hospital of Philadelphia

People needed

30

Starts

2024-08-07

Expected to finish

2027-12-01

Last updated by the study team

2025-12-04

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Participants with primary tumors of the spinal cord.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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