Study Title
An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
Study Details
Description:
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
Sponsor:
Telix PharmaceuticalsContacts:
Principal Investigatorinfo@telixpharma.com
Government Study Link:
NCT05861778 - Click here to see study onClinicalTrials.gov
- Mainland Chinese, male or female, >=18 years old
- Scheduled for lesion resection as part of regular diagnostic workup within 90days from planned TLX250-CDx administration
- Imaging evidence of a single indeterminate renal mass of <=7cm on CT or MRI that is suspicious for ccRCC
- Renal mass known to be a metastasis of another primary tumor
- Planned antineoplastic therapies for the period between administration and imaging
- Chemo-, radio-, immuno-, or targeted therapy w/in 4w prior to planned administration
- Multiple unilateral or bilateral indeterminate renal masses
- A biopsy procedure only (rather than partial or total nephrectomy) planned for histological species delineation of mass
Patient Education
Patient Education Not Yet Provided
Publications
Locations
Not yet provided. Contact Principal Investigator for more information.
info@telixpharma.com
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