Status:
COMPLETED
Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC
Lead Sponsor:
Telix Pharmaceuticals (Innovations) Pty Limited
Conditions:
Carcinoma, Renal Cell
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (...
Detailed Description
Phase 1: The phase 1 component of this study will be conducted in in 6-10 subjects at one study center, with the objective of confirming the safety/tolerability and the whole-body dose distribution o...
Eligibility Criteria
Inclusion
- Phase 1:
- Written and voluntarily given informed consent
- Aged ≥20 years at the time of enrollment
- Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI performed within 90 days before screening
- Sufficient life expectancy to participate in the study
- 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
- Written and voluntarily given informed consent
- Aged ≥20 years at the time of enrollment
- Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in largest diameter on CT or MRI within 90 days prior to screening
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
- Sufficient life expectancy to undergo nephrectomy
- 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
- Commonly applied for Phase 1 part and Phase 2 part
- Those who have hypersensitivity to Girentuximab or DFO
- Patients with metastatic renal tumor
- Patients who need treatment for other active malignancies during the study period
- 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
- Patients scheduled for anticancer drug treatment during the period from administration of investigational drug to image collection
- Patients who have been exposed to mouse or chimeric antibody within the past 5 years
- Patients who have been administered some kind of radionuclide earlier than 10 half-lives of the nuclide.
- Patients with severe, but not fatal disease, for which the principal investigator / investigator has determined that study participation is not appropriate
- 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
- 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
- Patients who cannot give legally valid consent by himself / herself
- Patients with renal dysfunction whose GFR is 60mL / min / 1.73m2 or less
- Patents who are socially vulnerable (e.g., patients in custody)
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04496089
Start Date
August 1 2020
End Date
April 6 2021
Last Update
August 24 2021
Active Locations (1)
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1
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004