89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Completed · Phase 3
Conditions studied: Clear Cell Renal Cell Carcinoma
In brief
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Key facts
- Study ID
- NCT03849118
- Run by
- Telix Pharmaceuticals (Innovations) Pty Limited
- People needed
- 300
- Starts
- 2019-08-15
- Expected to finish
- 2022-11-07
- Last updated by the study team
- 2024-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- University of California, Los Angeles Campus, — Los Angeles, California, United States
- Emory University — Atlanta, Georgia, United States
- Johns Hopkins University Hospital — Baltimore, Maryland, United States
- Advanced Molecular Imaging & Therapy, LLC — Glen Burnie, Maryland, United States
- Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States
- Washington University St Louis — St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- SEATTLE CANCER CARE ALLIANCE, University of Washington — Seattle, Washington, United States
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- Macquarie University Hospital — Sydney, New South Wales, Australia
- Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Austin Health — Heidelberg, Victoria, Australia
- Victorian Comprehensive Cancer Centre — Melbourne, Victoria, Australia
- Cabrini Hospital — Melbourne, Victoria, Australia
- Institute Jules Bordet — Brussels, Belgium
- University Hospital Leuven (UZ Leuven) — Leuven, Belgium
- Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM ) — Montreal, Quebec, Canada
- Jewish General Hopsital — Montreal, Quebec, Canada
- CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec — Québec, Canada
- CHU de Bordeaux, Groupe hospitalier Pellegrin — Bordeaux, France
- CHRU de Nancy, Hopitaux de Brabois — Nancy, France
- Nantes University Hospital Hotel-Dieu — Nantes, France
- Netherlands Cancer Institute — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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