Title
An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-Fet, TLX101-CDX)

Description
An Expanded Access Program for the non-invasive characterization of glioma or treatment related change utilizing Fluorine (F-18) floretyrosine

Objective
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 non-invasively detect tumor burden or treatment related change to assist in optimal management of patients with glioma.
Within the EAP, additional data will be collected to support the safety and efficacy data obtained within previous clinical studies and improve patient management.

Treatment Adult participants will receive a single administration of 185 MBq (5 mCi) +/- 10 % 18F-Floretyrosine administered as an intravenous bolus injection. Pediatric participants (>/= 3 years of age) will receive weight-based dosing of 3MBq/kg up to 60 kg or 18 years of age. (Piccardo, et al., 2022). Participants will be eligible for repeat dosing and imaging if deemed medically necessary. Re-consent/updated assent will be required to be obtained for repeat dosing.

Key Eligibility All participants must meet all the following criteria prior to receiving 18F-Florestyrosine and undergoing imaging:

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.
2. Male or female >/= 3 years of age at time of consent/assent
3. Diagnosis or clinical suspicion of glioma (any grade) in the brain
4. At the time of screening have undergone therapy for glioma
5. 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
6. Willing and able to lie still for at least 40 minutes in an enclosed space for the imaging procedure, or if medically necessary, able to tolerate standard institutions procedures for sedation and/or anesthesia

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital; Wisconsin Institute for Medical Research (WIMR)