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

Phase 3

Completed

• Conditions: Clear Cell Renal Cell Carcinoma
• Interventions: Diagnostic Test: 89Zr-girentuximab

• Registration Number: NCT03849118
• Lead Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-08-15
• Primary Completion: 2022-10-20
• Study Completion: 2022-11-07
• Results First Submitted: 2024-02-22
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Results First Posted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Written and voluntarily given Informed Consent
2. Male or female ≥18 years of age
3. 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
4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
6. for patients included in France only, verification and confirmation of their affiliation with a social security
7. Sufficient life expectancy to justify nephrectomy
8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

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Exclusion Criteria

1. Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
2. Renal mass known to be a metastasis of another primary tumour
3. Active non-renal malignancy requiring therapy during the time frame of the study participation
4. 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)
5. Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
6. Exposure to murine or chimeric antibodies within the last 5 years
7. Previous administration of any radionuclide within 10 half-lives of the same
8. 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
9. Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
11. Women who are pregnant or breastfeeding
12. Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
13. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
14. Vulnerable patients (e.g being in detention)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
89Zr-girentuximab	89Zr-girentuximab	A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.	Diagnostic PET/CT scan on Day 5 ± 2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth.	This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion

Trial Locations

Locations (31)

University of California, Los Angeles Campus,; 🇺🇸 Los Angeles, California, United States

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

SEATTLE CANCER CARE ALLIANCE, University of Washington; 🇺🇸 Seattle, Washington, United States

Jewish General Hopsital; 🇨🇦 Montréal, Quebec, Canada

Barbara Ann Karmanos Cancer Hospital; 🇺🇸 Detroit, Michigan, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Institute Jules Bordet; 🇧🇪 Brussels, Belgium

Johns Hopkins University Hospital; 🇺🇸 Baltimore, Maryland, United States

Advanced Molecular Imaging & Therapy, LLC; 🇺🇸 Glen Burnie, Maryland, United States

Washington University St Louis; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Macquarie University Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Austin Health; 🇦🇺 Heidelberg, Victoria, Australia

Victorian Comprehensive Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

University Hospital Leuven (UZ Leuven); 🇧🇪 Leuven, Belgium

Cabrini Hospital; 🇦🇺 Melbourne, Victoria, Australia

Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM ); 🇨🇦 Montréal, 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

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands

Hacettepe University Faculty of Medicine; 🇹🇷 Ankara, Turkey

Ankara University Medical Faculty Hospital; 🇹🇷 Ankara, Turkey

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Istanbul University Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom