Actively Recruiting
Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma HGG
Led by Children's Hospital of Philadelphia · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
52 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
Researchers are evaluating whether 18F-fluciclovine Axumin PET imaging can help doctors distinguish between true tumor growth and other changes in children with high-grade gliomas, including diffuse midline glioma. This distinction is important because true tumor progression may require a change in treatment, while post-treatment changes usually do not. Conventional MRI scans cannot reliably make this differentiation, so this study aims to see if 18F-fluciclovine PET imaging can serve as a useful diagnostic tool. Participants will receive a single intravenous injection of 18F-fluciclovine before undergoing a combined PET-MRI scan. This imaging process is designed to assess tumor status by detecting physiological changes. The study focuses on children and young adults aged 1 to under 21 years with measurable high-grade gliomas or diffuse midline gliomas. The study is an early phase 1 trial, and treatment involves only this one-time imaging procedure. During the study, researchers will analyze the imaging results and compare them to histopathology findings within four weeks and evaluate safety over six months. Participants will be monitored for any side effects related to the imaging agent. The study will assess the usefulness and safety of 18F-fluciclovine PET-MRI in guiding treatment decisions for pediatric high-grade glioma. Participation lasts through these assessments, with imaging and follow-up evaluations scheduled accordingly.
CONDITIONS
Brief 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 characteristic imaging of diffuse intrinsic pontine gliomas (DIPG).
- Measurable tumor of at least 1x1 cm.
- Life expectancy greater than 8 weeks.
- Age greater than 1 year and less than 21 years at enrollment.
- For those without planned surgery: clinical or radiographic suspicion of true progression or pseudoprogression during radiation or on first post-radiation MRI.
- For those with planned surgery: suspicion of tumor progression with plan for surgery or biopsy.
You will not qualify if you...
- Inability to tolerate imaging procedures as judged by investigator or physician.
- Pregnant or breastfeeding.
- Need for sedation or anesthesia for imaging beyond standard of care.
- Weighing less than 8 kilograms.
- Unable to avoid contact with pregnant woman or infant for at least 12 hours after injection.
- History of abnormal kidney function or creatinine at or above CTCAE v5.0 grade 2.
- Primary tumors located in the spinal cord.
Research Team
M
Mariam Aboian, MD, PhD
N
Nazanin Maleki, MD
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