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Telix Pharma's ZIRCON-X Study Shows TLX250-CDx Imaging Could Alter Clinical Management In Nearly Half of Patients

Author: Benzinga Newsdesk | November 19, 2025 02:03pm

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab) PET/CT would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Phoenix, AZ, December 2 – 5, 2025.

ZIRCON-X was a non-interventional, prospective, post-hoc study sponsored by Telix – using imaging data from Telix's parent pivotal Phase 3 ZIRCON study – that assessed the impact of TLX250-CDx imaging on clinical decision-making versus SOC contrast-enhanced diagnostic imaging in 294 patients with indeterminate renal masses (IRMs)4. The study found that 143 patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-CDx, and over 20% of these patients (31 out of 143) could have potentially avoided invasive biopsy.

Of all evaluable patients, more than one third (110 out of 294, or 37.4%) would have had a major change in clinical management based on defined categories (see table below), with approximately 30% having their treatment escalated or de-escalated. A subset of 18 patients initially selected for active surveillance would have been escalated to immediate treatment.

Posted In: TLX

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