Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
The Children s Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Mariam Aboian, MD, PhD
aboianm@chop.edu
215-510-7661
Backup
Nazanin Maleki, MD
malekin@chop.edu
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-09
Participants
Target number of participants: 30
Treatments
Experimental: 18F-Fluciclovine
18F-Fluciclovine PET-MRI
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: Blue Earth Diagnostics, Dragon Master Foundation

This content was sourced from clinicaltrials.gov