Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Early Phase 1

Recruiting

• Conditions: Glioma; Low-grade Glioma; Low Grade Glioma of Brain; Glioma, Malignant; Glioma Intracranial
• Interventions: Drug: 18F-Fluciclovine

• Registration Number: NCT05555550
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-03-03
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

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

Inclusion Criteria

• LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
• Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
• Scheduled to receive systemic therapy
• Performance Score: Karnofsky ≥ 50 for participants > 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Age between ≥ 1 years but ≤21 years at time of study registration

Exclusion Criteria

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
2. Pregnant participants
3. Patient who would require sedation or anesthesia for imaging beyond 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	18F-Fluciclovine	18F-Fluciclovine PET-MRI

Primary Outcome Measures

Name	Time	Method
Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET	1 year	To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan
Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG	1 year	Calculate the change in tumor measurement on MRI

Secondary Outcome Measures

Name	Time	Method
Safety of 18F-Fluciclovine	13 months	The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

Trial Locations

Locations (1)

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