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

This is an interventional health services research trial for Carcinoma, Renal Cell focused on measuring clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab, pharmacokinetics, pharmacodynamics, safety, Diagnostic imaging, 89Zr-TLX250 Read More

Inclusion Criteria:

Phase 1:

1. Written and voluntarily given informed consent
2. Aged ≥20 years at the time of enrollment
3. Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI performed within 90 days before screening
4. Sufficient life expectancy to participate in the study
5. Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively

Phase 2 Part

1. Written and voluntarily given informed consent
2. Aged ≥20 years at the time of enrollment
3. Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in largest diameter on CT or MRI within 90 days prior to screening
4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
5. Sufficient life expectancy to undergo nephrectomy
6. Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively

Exclusion Criteria:

Commonly applied for Phase 1 part and Phase 2 part

1. Those who have hypersensitivity to Girentuximab or DFO
2. Patients with metastatic renal tumor
3. Patients who need treatment for other active malignancies during the study period
4. Patients who have undergone chemotherapy, radiation therapy, or immunotherapy within 4 weeks before the administration of the investigational drug, or have continued adverse events of grade 1 (defined in NCI-CTCAE v5.0) or higher
5. Patients scheduled for anticancer drug treatment during the period from administration of investigational drug to image collection
6. Patients who have been exposed to mouse or chimeric antibody within the past 5 years
7. Patients who have been administered some kind of radionuclide earlier than 10 half-lives of the nuclide.
8. Patients with severe, but not fatal disease, for which the principal investigator / investigator has determined that study participation is not appropriate
9. Women who are pregnant or breastfeeding. And women with childbearing potential who are not pregnant or breastfeeding but suspected of being pregnant by the blood test at screening and pre-dose (within 24 hours before administration). Pre-dose blood pregnancy test can be replaced with urine test
10. Patients who have been administered the drug by any clinical study or clinical trial within 30 days before the scheduled administration of the investigational drug
11. Patients who cannot give legally valid consent by himself / herself
12. Patients with renal dysfunction whose GFR is 60mL / min / 1.73m2 or less
13. Patents who are socially vulnerable (e.g., patients in custody)
14. Others who are judged by the principal investigator or investigator to be inappropriate for participation in this trial Applied only to Phase 2 part 15． Patients whose biopsy is more suitable for pathological diagnosis than partial resection or nephrectomy