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

Clear Cell Renal Cell Carcinoma Clinical Trial

— 89ZR-TLX250  

Official title:

A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849118
• Other study ID #: 89Zr-TLX250-003
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2019
• Est. completion date: November 7, 2022

Study information

• Verified date: May 2024
• Source: Telix Pharmaceuticals (Innovations) Pty Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 7, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Diagnostic Test:
• 89Zr-girentuximab
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Telix Pharmaceuticals (Innovations) Pty Limited

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Netherlands,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.