For people living with glioma, follow-up imaging can bring one of the hardest questions in brain cancer care: is the tumor returning or progressing, or does the scan reflect changes caused by treatment? Magnetic resonance imaging (MRI) remains central to care, but surgery, radiation and other treatments can alter brain tissue in ways that may resemble active disease. When the picture is unclear, patients, families and care teams may face further testing and difficult decisions.
A new FDA-approved imaging option
In September 2026, the U.S. Food and Drug Administration approved Pixclara® (floretyrosine F 18), also known as 18F-FET, for use with positron emission tomography (PET) scan to help differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations. The indication includes adults and pediatric patients one month of age and older.
Pixclara is the first and only FDA-approved FET-PET imaging drug for glioma. FET-PET is an amino acid imaging approach that provides information about biological activity rather than anatomy alone. After administration into the bloodstream, Pixclara targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). Once bound, energy emissions from its fluorine-18 radioisotope are then detected by a PET scanner, producing images that clinicians interpret alongside MRI, clinical history and other diagnostic information.
From approval to the first patients
The first U.S. commercial doses of Pixclara were administered soon after approval at Indiana University Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center. FET-PET imaging is already recognized in international clinical practice guidelines, including the National Comprehensive Cancer Network® Guidelines. Until the approval of Pixclara, however, there was no FDA-approved FET-PET product commercially available in the United States. Pixclara therefore gives clinicians another imaging tool when evaluating patients after treatment, particularly when MRI findings are unclear.
What patients and care partners can ask
Patients and care partners may wish to ask whether amino acid PET imaging is appropriate for their situation, how it would complement existing scans and how the results could inform treatment planning or monitoring. Availability may vary by imaging center, and the decision to use Pixclara should be made with the treating care team.
Pixclara brings an established imaging approach to the United States through an FDA-approved product, giving glioma care teams another way to investigate whether changes seen after treatment reflect disease or treatment-related effects.
To learn more about Telix’s brain portfolio, including the active Phase 3 IPAX BrIGHT trial of therapeutic candidate TLX101-Tx in recurrent glioblastoma, visit: telixpharma.com/brain
U.S. healthcare professionals can explore more on the diagnostic challenges in gliomas here:
gliomagrayareas.com
Please see Pixclara Full Prescribing Information and Important Safety Information
