NCT03849118

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

Detailed description

This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy. Patients, will be recruited in 12-15 renal cancer care specialist centres, who have access to state-of-the-art PET/CT imaging equipment. The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted 5 +/-2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	89Zr-girentuximab	Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.

Timeline

• Start date: 2019-08-15
• Primary completion: 2022-10-20
• Completion: 2022-11-07
• First posted: 2019-02-21
• Last updated: 2024-05-17
• Results posted: 2024-05-17

Locations

31 sites across 8 countries: United States, Australia, Belgium, Canada, France, Netherlands, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study