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Clinical Trial Summary

This phase Ib/II study will evaluate the use of 89Zr-girentuximab in the staging of urothelial carcinoma. The primary objective of this study is to compare the sensitivity and specificity of 89Zr-girentuximab PET with FDG-PET in the staging of urothelial carcinoma.


Clinical Trial Description

This study will evaluate the use of 89Zr-girentuximab in the staging of urothelial carcinoma. The primary objective of this study is to compare the sensitivity and specificity of 89Zr-girentuximab PET with FDG-PET in the staging of urothelial carcinoma. The study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05018442
Study type Interventional
Source Telix International Pty Ltd
Contact Dickon Hayne, Prof
Phone +61 8 6152 6916
Email dickon.hayne@uwa.edu.au
Status Recruiting
Phase Phase 1/Phase 2
Start date August 3, 2021
Completion date May 31, 2022

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