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Clinical Trial · NCT05861778
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
Overview
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 PharmaceuticalsPhase
Phase 1
Contacts
Principal Investigator
info@telixpharma.com
ClinicalTrials.gov
NCT05861778Drug / Compound
Isotope(s):
ZIRCONIUM-89
Radioisotope: Zr89
Theranostic Role: PET Imaging
T1/2 (Half-Life): 78 Hours
Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
Range: N/A
Decay Daughters: Y89 (Stable)
Status: Clinical Trials Only
Target(s):
Eligibility
Inclusion
- 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
Exclusion
- 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.
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