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Clinical Trial · NCT05046665
Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients
Overview
The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer. The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.
Eligibility
Inclusion
- Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
- Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
Exclusion
- Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
- Serious non-malignant disease that may interfere with the objectives of the study
- Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
- Known hypersensitivity or human anti-chimeric antibodies against girentuximab
- Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
- Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
- Active malignancy other than urothelial carcinoma or bladder cancer
- Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
- Pregnancy or lactation
- Exposure to murine or chimeric antibodies within the last 5 years
- Contraindications to FDG PET/CT
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