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An open-label, Phase I study to assess safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labelled girentuximab (89Zr-girentuximab) for in vivo detection of clear cell renal carcinoma (CCRC) by positron emission tomography (PET) using different PET imaging methodologies.

The identification of RCC is crucial for planning possible surgery and treatment. The aim of this study is to investigate the safety, tolerability, radiation dosimetry, as well as the diagnostic performance of 89Zr-girentuximab PET/CT in patients…

A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)

Primary Objective:To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.Secondary…