18F-Fluciclovine PET-MRI in High-grade Glioma

Early Phase 1

Recruiting

• Conditions: Diffuse Glioma; Glioma; High Grade Glioma; Glioma Intracranial; Glioma, Malignant
• Interventions: Drug: 18F-Fluciclovine PET-MRI

• Registration Number: NCT05553041
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical.

The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2023-08-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• 2. Pregnant or breastfeeding participants.
• 3. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).
• 4. Participants who weigh less than 8 kg.
• 5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.

• 6. Participants with a history of abnormal kidney function or creatinine >= CTCAE v5.0 grade 2 at time of study registration.

  7. Participants with primary tumors of the spinal cord.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants	18F-Fluciclovine PET-MRI	Single intravenous administration of 18F fluciclovine for PET-MRI Scan

Primary Outcome Measures

Name	Time	Method
Histopathology analysis	4 weeks	Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.
Image analysis	6 months	Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.

Secondary Outcome Measures

Name	Time	Method
Safety of 18F-Fluciclovine	6 months	The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States