Clinical Trial · NCT05555550

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

Overview

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.

Sponsor

Children's Hospital of Philadelphia

Phase

Early Phase 1

Contacts

Nazanin Maleki, MD (CONTACT)

malekin@chop.edu

Mariam Aboian, MD, PhD (CONTACT)

aboianm@chop.edu

215-510-7661

Mariam Aboian, MD,PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05555550

Drug / Compound

Fluciclovine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

Participants must have evaluable disease (1x1 cm tumor on MRI)
Participants who weigh less than 8 kg.
Participants with primary tumors of the spinal cord.
Scheduled to receive systemic therapy for LGG
LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.

Exclusion

Exclusion criteria not yet provided.