ACTRN12621000411842
Not yet recruiting
Phase 1
A single-centre, open-label, phase I study to evaluate the diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients
South Metropolitan Health Services0 sites20 target enrollmentApril 15, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic urothelial carcinoma
- Sponsor
- South Metropolitan Health Services
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
- •2\.Negative serum pregnancy test in female patients of childbearing potential at screening and consent to practise double\-barrier contraception until a minimum of 42 days after 89Zr\-TLX250 administration.
- •3\. Histologically diagnosed with urothelial carcinoma or bladder cancer (or upper tract urothelial carcinoma diagnosed based on standard imaging and malignant urine cytology or direct visualisation on ureteroscopy) or known metastatic urothelial carcinoma or bladder cancer (based on previous imaging and /or histopathology)
Exclusion Criteria
- •1\.Active malignancy other than urothelial carcinoma or bladder cancer
- •2\.Administration of a radioisotope within 10 physical half\-lives prior to study enrolment.
- •3\.Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr\-TLX250 or continuing adverse effects from such therapy
- •4\.Planned antineoplastic therapies for the period between administration of 89Zr\-TLX250 and imaging
- •5\.Serious non\-malignant disease that may interfere with the objectives of the study
- •6\.Renal insufficiency with glomerular filtration rate less than or equal to 45 mL/min/1\.73m2
- •7\.Pregnancy or lactation
- •8\.Exposure to murine or chimeric antibodies within the last 5 years
- •9\.Known hypersensitivity or human anti\-chimeric antibodies against girentuximab
- •10\.Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr\-TLX250
Outcomes
Primary Outcomes
Not specified
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