Kettering Health is the first hospital in an Expanded Access Program (EAP) led by Telix, a global pharmaceutical company, to offer patients access to TLX101-CDx (¹⁸F-floretyrosine or ¹⁸F-FET), a PET imaging agent that can help to quickly identify the recurrence of glioma brain tumors, the most common and aggressive form of brain cancer, making early intervention critical to improving patient outcomes. 

Early access to imaging

As a participating member of Telix’s Food and Drug Administration (FDA)-approved Expanded Access Program for TLX101-CDx, Kettering Health Main Campus has been granted authorization to provide eligible brain tumor patients with early access to the PET imaging agent to address the need for advancements in brain cancer diagnoses. Expanded access designation is given to medical products pending FDA approval where they have demonstrated their ability to address an unmet medical need, with an acceptable safety profile.

“Time is of the essence when treating glioma tumors due to their aggressive nature,” said Dr. Mark Hoeprich, neurosurgeon and principal investigator for the EAP for molecular imaging at Kettering Health. “This advancement in precision imaging will enhance our ability to see where and how these cancerous cells are acting in the brain, ultimately allowing us to act faster when it comes to treating them.”

How it works

TLX101-CDx is a tracer used in PET (Positron Emission Tomography), an imaging method used in nuclear medicine, a specialized field of radiology that uses small, safe amounts of radioactive material to identify and diagnose a variety of diseases. Once injected, tracers circulate through the bloodstream until they reach their target, allowing physicians to use PET scans to take pictures of the inside of the body and gather information about biochemical process for diagnosis and treatment.

¹⁸F-FET PET (also known as FET-PET) potentially offers more precise imaging capabilities over conventional imaging due to its enhanced ability to locate gliomas via a biochemical reaction. This technology stands in stark contrast to an indirect measure of tumor recurrence dependent on a cancer’s ability to create its own, leaky vasculature, which is the basis for contrast enhanced MRI brain tumor imaging.

“Kettering Health has a demonstrated history of being at the forefront of advancements in nuclear medicine and high-precision imaging,” said Hoeprich. “This is a testament to our commitment to continuously find ways to help our patients live longer, healthier lives. Being the first in Telix’s nationwide EAP to offer TLX101-CDx has allowed us to continue leading the way in providing access to new PET diagnostics and precision treatments.” 

FET-PET is in clinical use in countries outside the United States and TLX101-CDx has been accepted for priority review by the FDA. If approved by the FDA, TLX101-CDx is expected to become the first commercially-available PET tracer expressly approved to detect glioma tumors in the United States. A fact sheet with more information about nuclear medicine at Kettering Health, glioma tumors, TLX101-CDx, and Expanded Access Programs is attached.