Status:
COMPLETED
89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Lead Sponsor:
Telix Pharmaceuticals (Innovations) Pty Limited
Conditions:
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Detailed Description
This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to ...
Eligibility Criteria
Inclusion
- Written and voluntarily given Informed Consent
- Male or female ≥18 years of age
- Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
- Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
- for patients included in France only, verification and confirmation of their affiliation with a social security
- Sufficient life expectancy to justify nephrectomy
- Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration
Exclusion
- Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
- Renal mass known to be a metastasis of another primary tumour
- Active non-renal malignancy requiring therapy during the time frame of the study participation
- Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
- Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
- Exposure to murine or chimeric antibodies within the last 5 years
- Previous administration of any radionuclide within 10 half-lives of the same
- Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
- Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
- Women who are pregnant or breastfeeding
- Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
- Vulnerable patients (e.g being in detention)
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03849118
Start Date
August 15 2019
End Date
November 7 2022
Last Update
May 17 2024
Active Locations (31)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of California, Los Angeles Campus,
Los Angeles, California, United States, 90095
3
Emory University
Atlanta, Georgia, United States, 30322
4
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21287