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Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC

Telix Pharmaceuticals (Innovations) Pty Limited · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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carcinomadiagnostic-imagingpharmacodynamicspharmacokineticsrenal-cellsafety
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.
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