Kidney Cancer Clinical Trial

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

Summary

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

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Full 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 non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy.

Patients, will be recruited in 12-15 renal cancer care specialist centres, who have access to state-of-the-art PET/CT imaging equipment.

The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted 5 +/-2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.

On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator.

Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT03849118

Recruitment Status:

Completed

Sponsor:

Telix Pharmaceuticals (Innovations) Pty Limited

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There are 28 Locations for this study

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City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
University of California, Los Angeles Campus,
Los Angeles California, 90095, United States
Emory University
Atlanta Georgia, 30322, United States
Johns Hopkins University Hospital
Baltimore Maryland, 21287, United States
Advanced Molecular Imaging & Therapy, LLC
Glen Burnie Maryland, 21061, United States
Barbara Ann Karmanos Cancer Hospital
Detroit Michigan, 48201, United States
Washington University St Louis
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
SEATTLE CANCER CARE ALLIANCE, University of Washington
Seattle Washington, 98109, United States
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Macquarie University Hospital
Sydney New South Wales, 2109, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Victorian Comprehensive Cancer Centre
Melbourne Victoria, 3000, Australia
Cabrini Hospital
Melbourne Victoria, , Australia
Institute Jules Bordet
Brussels , 1000, Belgium
University Hospital Leuven (UZ Leuven)
Leuven , 3000, Belgium
Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )
Montréal Quebec, H2X0C, Canada
Jewish General Hopsital
Montréal Quebec, H3T 1, Canada
CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec
Québec , G1R2J, Canada
CHU de Bordeaux, Groupe hospitalier Pellegrin
Bordeaux , 33076, France
CHRU de Nancy, Hopitaux de Brabois
Nancy , 54500, France
Nantes University Hospital Hotel-Dieu
Nantes , 44000, France
Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands
Radboud University Medical Centre
Nijmegen , 6500 , Netherlands
Ankara University Medical Faculty Hospital
Ankara , 06100, Turkey
Hacettepe University Faculty of Medicine
Ankara , 06230, Turkey
Istanbul Training and Research Hospital
Istanbul , 34098, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Royal Free London NHS Foundation Trust
London , NW3 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT03849118

Recruitment Status:

Completed

Sponsor:


Telix Pharmaceuticals (Innovations) Pty Limited

How clear is this clinincal trial information?

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