Risk Stratification of Pediatric Patients With Neuroblastoma Using Volumetric Parameters of 18F-FDG and 18F-DOPA PET/CT.
Chia-Ju Liu, Meng-Yao Lu, Yen-Lin Liu...
https://pubmed.ncbi.nlm.nih.gov/28072621/Actively Recruiting
Led by Children's Hospital of Philadelphia · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers are evaluating the usefulness and safety of 18F-Fluciclovine Axumin in managing children and young adults with Low Grade Gliomas LGG, a type of brain tumor. This early phase 1 trial focuses on using 18F-Fluciclovine PET-MRI scans to observe tumor changes over time and compare these to standard MRI measurements. The study aims to improve understanding of tumor behavior during treatment in this young population. Participants will receive an injection of 18F-Fluciclovine before undergoing PET-MRI imaging. Scans will be performed before starting therapy for LGG, then again at 3 months and 1 year after treatment begins. The study will measure changes in the tumors uptake of 18F-Fluciclovine and compare them to MRI tumor size changes over the same periods. During the study, participants will have PET-MRI scans and standard MRI assessments at the scheduled times. Researchers will monitor tumor activity using standardized uptake values SUVmax and SUVpeak on the PET scans and tumor size on MRI. Safety of the 18F-Fluciclovine injection will also be tracked over 13 months. The total participation time is about one year with follow-up to evaluate these imaging outcomes and safety.
CONDITIONS
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
M
Mariam Aboian, MD, PhD
N
Nazanin Maleki, MD
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Children's Hospital of Philadelphia
Lead Sponsor
Blue Earth Diagnostics
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 18F-Fluciclovine PET-MRI | Standard MRI (Current Practice) |
|---|---|---|
| What it is | A combined PET-MRI scan using the injectable tracer 18F-Fluciclovine, performed in addition to the usual brain MRI to help visualize tumor features in pediatric low-grade glioma. | Standard MRI-only imaging is the established clinical approach for diagnosis, tumor assessment, and routine monitoring in pediatric low-grade glioma. |
| Role in trial | Evaluated to determine if PET-MRI using 18F-Fluciclovine provides additional or superior information compared to MRI before systemic therapy begins. | Serves as the established reference imaging strategy for tumor detection, characterization, and treatment response. |
| Primary use | To assess tumor size, metabolic activity, and possible progression or response to therapy by measuring amino acid tracer uptake in the tumor, in addition to anatomic MRI detail. | To visualize the location, size, and features of low-grade glioma and monitor changes during and after treatment using magnetic resonance imaging techniques. |
| How it is given or performed | Participants receive an intravenous injection of 18F-Fluciclovine, followed by a PET scan and standard MRI within the same imaging session. | MRI is performed without the PET tracer, usually with contrast enhancement, following clinical protocols for brain tumor imaging. |
| Evidence maturity | Evidence from early clinical trials, including one multicenter Phase IIb study, suggests 18F-Fluciclovine PET adds diagnostic value in glioma, but further studies are needed, especially in pediatric low-grade glioma. | Supported by extensive clinical evidence and guideline consensus as the routine imaging method for pediatric low-grade glioma diagnosis and monitoring. |
| Important limitations | Limited experience in children; may not distinguish all tumor subtypes or grades; involves exposure to a radioactive tracer. Not yet established for routine use in pediatric low-grade glioma. | MRI may not fully capture tumor metabolic activity or distinguish active tumor from treatment-related changes. Some tumor features are difficult to assess without complementary imaging. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive an injection of 18F-Fluciclovine prior to PET-MRI imaging to evaluate tumor characteristics.
1 visit (in-person)
Duration - Up to 13 months
Participants are monitored for safety and changes in tumor measurements over time following the imaging evaluation.
Follow-up visits as scheduled for up to 13 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Lead Sponsor
Blue Earth Diagnostics
Collaborating Sponsor