Actively Recruiting
Phase 3 Study of 89Zr-TLX250 PETCT Imaging to Detect Clear Cell Renal Cell Carcinoma in Chinese Adults with Indeterminate Renal Masses
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-12-27
82
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma ccRCC in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PETCT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PETCT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PETCT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.
CONDITIONS
Brief Title
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Mainland Chinese male or female aged 18 years or older
- Imaging shows a single indeterminate renal mass 7 cm or smaller, done within 90 days before study start
- Scheduled for partial or total nephrectomy within 90 days after 89Zr-TLX250 administration
- Negative serum pregnancy test for women of childbearing potential at screening and urine test within 24 hours before study drug
- Life expectancy sufficient to justify nephrectomy
- Agree to use highly effective contraception until at least 42 days after study drug administration
You will not qualify if you...
- Only biopsy planned instead of partial or total nephrectomy
- Renal mass known to be metastasis from another primary tumor
- Active non-renal cancer requiring treatment during study participation
- Multiple indeterminate renal masses on one or both kidneys
- Chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks before study drug or ongoing significant side effects from such treatments
- Planned cancer treatments between study drug administration and imaging
- Exposure to murine or chimeric antibodies within last 5 years
- Previous radionuclide administration within 10 half-lives
- Serious non-cancer diseases affecting safety or study compliance
- Mental impairment affecting consent or study compliance
- Exposure to experimental drugs within 4 weeks or 5 half-lives before study drug
- Pregnant or breastfeeding women
- Known allergy to girentuximab or desferoxamine
- Kidney function with glomerular filtration rate 45 mL/min/1.73 m² or less
- Vulnerable individuals such as those in detention
Research Team
L
Lily Nahidi
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