Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Mariam Aboian, MD, PhD
aboianm@chop.edu
215-510-7661
Backup
Nazanin Maleki, MD
malekin@chop.edu
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants
Single intravenous administration of 18F fluciclovine for PET-MRI Scan
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: Blue Earth Diagnostics, Dragon Master Foundation

This content was sourced from clinicaltrials.gov