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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 29 Mar 2024

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At a glance

  • Drugs Girentuximab Zr-89 (Primary)
  • Indications Renal cell carcinoma; Sarcoma
  • Focus Diagnostic use; Registrational
  • Acronyms ZIRCON
  • Sponsors Telix Pharmaceuticals

    • Most Recent Events

    • 19 Dec 2023 According to a Telix Pharmaceuticals media release , the company announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix™,[1] 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) based upon this study.
    • 18 Oct 2023 According to a Telix Pharmaceuticals media release , company Company has received a formal acceptance letter from the FDA in response to a request for a rolling review of the BLA.The Company continues to progress its BLA submission in 2023 as planned.
    • 06 Sep 2023 According to a Telix Pharmaceuticals media release, data from this study will be presented at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) on Sunday 10 September.
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