Actively Recruiting
18F-Fluciclovine PET-MRI in High-grade Glioma
Led by Children's Hospital of Philadelphia · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
18F-Fluciclovine PET-MRI in High-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathology-proven high-grade glioma (WHO grade III-IV) or diffuse midline glioma (WHO grade IV), or imaging characteristic of diffuse intrinsic pontine gliomas involving ≥2/3 of the pons
- Measurable disease of at least 1x1 cm
- Life expectancy greater than 8 weeks
- Age greater than 1 year and less than 21 years at enrollment
- For participants without planned surgery: clinical or radiographic suspicion of true progression or pseudoprogression during radiation before the initial post-radiation MRI, or suspicion on first post-radiation MRI
- For participants with planned surgery: clinical or radiographic suspicion of tumor progression with plan for surgery or biopsy
You will not qualify if you...
- Unable to tolerate imaging procedures as judged by investigator or treating physician
- Pregnant or breastfeeding participants
- Need for sedation or anesthesia for imaging beyond standard of care
- Weight less than 8 kilograms
- Cannot avoid contact with pregnant women or infants for at least 12 hours after injection
- History of abnormal kidney function or creatinine ≥ CTCAE v5.0 grade 2 at registration
- Primary tumors of the spinal cord
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mariam Aboian, MD, PhD
CONTACT
N
Nazanin Maleki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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