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Clinical Trial · NCT06743100
18F-Floretyrosine Expanded Access Program
Overview
The aim of this Expanded Access Program (EAP) is to enable the use of 18F-Floretyrosine with positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance (PET/MR) imaging to noninvasively detect tumor burden or treatment related change to assist in optimal management of patients with glioma.
Sponsor
Telix PharmaceuticalsClinicalTrials.gov
NCT06743100Drug / Compound
Floretyrosine
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):
- O-(2-[18F]-fluoroethyl)-L-tyrosine (FET)
Ligand Class: Small Molecules
Eligibility
Inclusion
- 1. Written and voluntarily given informed consent. Pediatric patients (\<18 years of age) will provide assent along with parental/legal guardian /caregiver consent according to IRB requirements.
- At the time of screening have undergone therapy for glioma
- Male or female ≥ 3 years of age at time of consent/assent
- Diagnosis or clinical suspicion of glioma (any grade) in the brain
- Indeterminate MR findings for disease recurrence or progression versus treatment related changes (pseudoprogression or pseudoresponse) requiring further diagnostic procedures within 60 days prior to the 18F-Floretyrosine PET imaging
Exclusion
- Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of the program (Day 0 to Day 2).
- Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the participant, as judged by the Investigator.
- Women who are pregnant or breastfeeding.
- 1. Participant cannot be safely scanned due to devices, implants, foreign and/or metallic objects in or on the body that are not MR compatible, unless a clinical judgement is made that the participant's diagnostic needs can instead be met by diversion to 18F-Floretyrosine imaging by PET/CT (making the magnetic field compatibility an irrelevant safety concern).
- Mental impairment that may compromise the ability to give informed consent/assent and comply with the requirements of the program as judged by the Investigator.
Patient Education
Patient education not yet provided.
Publications
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