Cerebral blood flow changes after radiation therapy identifies pseudoprogression in diffuse intrinsic pontine gliomas.
Raphael Calmon, Stephanie Puget, Pascale Varlet...
https://pubmed.ncbi.nlm.nih.gov/29244086Actively Recruiting
Early Phase 1
Age: 1Year - 21Years
All Genders
ID05553041
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
Age: 1Year - 21Years
All Genders
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants receive a single intravenous injection of 18F-Fluciclovine followed by a PET-MRI scan to help differentiate tumor progression from post-treatment changes.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 6 months
Participants are monitored for safety and imaging outcomes after the diagnostic scan.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
M
Mariam Aboian, MD, PhD
N
Nazanin Maleki, MD
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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Published Research Related To This Trial
Pseudoprogression in children, adolescents and young adults with non-brainstem high grade glioma and diffuse intrinsic pontine glioma.
Fernando Carceller, Lucy A Fowkes, Komel Khabra...
https://pubmed.ncbi.nlm.nih.gov/27180091Advanced ADC Histogram, Perfusion, and Permeability Metrics Show an Association with Survival and Pseudoprogression in Newly Diagnosed Diffuse Intrinsic Pontine Glioma: A Report from the Pediatric Brain Tumor Consortium.
S Vajapeyam, D Brown, C Billups...
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Shuntaro Oka, Ryota Hattori, Fumie Kurosaki...
https://pubmed.ncbi.nlm.nih.gov/17204698Differences in transport mechanisms of trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid in inflammation, prostate cancer, and glioma cells: comparison with L-[methyl-11C]methionine and 2-deoxy-2-[18F]fluoro-D-glucose.
Shuntaro Oka, Hiroyuki Okudaira, Masahiro Ono...
https://pubmed.ncbi.nlm.nih.gov/24136390Combined PET Imaging of the Inflammatory Tumor Microenvironment Identifies Margins of Unique Radiotracer Uptake.
Bastian Zinnhardt, Hayet Pigeon, Benoit Thézé...
https://pubmed.ncbi.nlm.nih.gov/2813776918F-Fluciclovine PET to distinguish treatment-related effects from disease progression in recurrent glioblastoma: PET fusion with MRI guides neurosurgical sampling.
Fraser Henderson, Steven Brem, Donald M O'Rourke...
https://pubmed.ncbi.nlm.nih.gov/32206320Diagnosis of pseudoprogression in patients with glioblastoma using O-(2-[18F]fluoroethyl)-L-tyrosine PET.
Norbert Galldiks, Veronika Dunkl, Gabriele Stoffels...
https://pubmed.ncbi.nlm.nih.gov/25411133