Trials / Recruiting
RecruitingNCT05555550
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F-Fluciclovine | 18F-Fluciclovine will be injected via IV prior to PET-MRI imaging |
Timeline
- Start date
- 2025-12-29
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2022-09-27
- Last updated
- 2025-12-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05555550. Inclusion in this directory is not an endorsement.