18F-Floretyrosine Expanded Access Program

May 26, 2026 updated by: Telix Pharmaceuticals (Innovations) Pty Limited

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • CU Anschutz / University of Colorado
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • MSKCC (Memorial Sloan Kettering Cancer Center)
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Health Main Campus
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • University Pennsylvania
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2275
        • University Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

  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).
  2. Women who are pregnant or breastfeeding.
  3. 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).
  4. 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.
  5. 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.
  6. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date planned administration of 18F-Floretyrosine.
  7. Known hypersensitivity to floretyrosine or tyrosine derivatives.
  8. Unable to tolerate the program procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-TLX101-CDX-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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