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Luke Nordquist, MD, FACP, CEO
drluke@xcancer.comTony Romero, MS, CCRC, Director of Research
tromero@gucancer.comEvaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Description:
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)Government Study Link:
NCT05555550 - Click here to see study onClinicalTrials.gov
Fluciclovine
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Amino Acid Transport
Ligand Class: Small Molecules
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
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