Actively Recruiting
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Led by Children's Hospital of Philadelphia · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with Low Grade Glioma (WHO grade I-II) in the brainstem or supratentorial region, confirmed by biopsy unless classic appearance in NF1
- Must have evaluable disease with at least 1x1 cm tumor visible on MRI
- Scheduled to begin systemic therapy for Low Grade Glioma
- Karnofsky score 65 50 if older than 16 years; Lansky score 65 50 if 16 years or younger; wheelchair-bound but ambulatory participants are included
- Age between 1 and 21 years at registration
- Being on a treatment regimen does not exclude participation
You will not qualify if you...
- Unable to tolerate imaging procedures as judged by physician
- Pregnant participants
- Weight less than 8 kilograms
- Unable to avoid contact with pregnant women or infants for at least 12 hours after injection
- History of abnormal kidney function or creatinine level 65 CTCAE v5.0 grade 2 at registration
- Primary tumors located in the spinal cord
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Children s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mariam Aboian, MD, PhD
CONTACT
N
Nazanin Maleki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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