Clear Cell Renal Cell CarcinomaPhase 389ZR-TLX250NCT03849118
89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
A Phase 3 study testing 89Zr-girentuximab in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 31 sites in 8 countries.
Trial summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- 89Zr-girentuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 15 Aug 2019to 7 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Advanced Molecular Imaging & Therapy, LLC
Glen Burnie, Maryland, 21061
University of California, Los Angeles Campus,
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
SEATTLE CANCER CARE ALLIANCE, University of Washington
Seattle, Washington, 98109
Washington University St Louis
St Louis, Missouri, 63110
Australia7 sites
Austin Health
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Victorian Comprehensive Cancer Centre
Melbourne, Victoria, 3000
Cabrini Hospital
Melbourne, Victoria
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Macquarie University Hospital
Sydney, New South Wales, 2109
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Turkey (Türkiye)4 sites
Ankara University Medical Faculty Hospital
Ankara, 06100
Hacettepe University Faculty of Medicine
Ankara, 06230
Istanbul Training and Research Hospital
Istanbul, 34098
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
Canada3 sites
Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )
Montreal, Quebec, H2X0C1
Jewish General Hopsital
Montreal, Quebec, H3T 1E2
CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec
Québec, G1R2J6
France3 sites
CHU de Bordeaux, Groupe hospitalier Pellegrin
Bordeaux, 33076
CHRU de Nancy, Hopitaux de Brabois
Nancy, 54500
Nantes University Hospital Hotel-Dieu
Nantes, 44000
Belgium2 sites
Institute Jules Bordet
Brussels, 1000
University Hospital Leuven (UZ Leuven)
Leuven, 3000
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Radboud University Medical Centre
Nijmegen, 6500 HB
United Kingdom1 site
Royal Free London NHS Foundation Trust
London, NW3 2QG
About this study
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
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Read the 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.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- 89Zr-girentuximab
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-girentuximabDiagnostic test
Also called 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-girentuximab | Experimental | 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. Receives: Diagnostic Test: 89Zr-girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start15 Aug 2019
- Primary completion20 Oct 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- diagnostic, confirmatory, prospective, multi-centre
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Gurney, MD, Principal investigator, Macquarie University HospitalFrancoise Brodere, MD, Principal investigator, University Hospital ICO, Nantes, FrancePeter Mulders, MD, Principal investigator, Radboud University Medical CenterMarcel Stokkel, MD, Principal investigator, The Netherlands Cancer InstituteDeclan Murphy, MD, Principal investigator, Victorian Comprehensive Cancer CentreAndrew Scott, MD, Principal investigator, Olivia Newton John Cancer Research Center, Austin HospitalSimon Wood, MD, Principal investigator, Princess Alexander HospitalMark Frydenberg, MD, Principal investigator, Cabrini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849118
- Sponsor's protocol ID
- 89Zr-TLX250-003
- Acronym
- 89ZR-TLX250
- Status last verified
- May 2024
- First submitted
- 29 Jan 2019
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chowdhury A, Morgat C, Bailly C, Sunderland J, Graves SA, Scott AM, Baker S, Holman BF. Radiation protection considerations with [89Zr]Zr-girentuximab PET and surgery. EJNMMI Res. 2025 May 23;15(1):59. doi: 10.1186/s13550-025-01247-1.
PubMed 40408016Shuch B, Pantuck AJ, Bernhard JC, Morris MA, Master V, Scott AM, van Praet C, Bailly C, Onal B, Aksoy T, Merkx R, Schuster DM, Lee ST, Pandit-Taskar N, Fan AC, Allman P, Schmidt K, Tauchmanova L, Wheatcroft M, Behrenbruch C, Hayward CRW, Mulders P. [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Oct;25(10):1277-1287. doi: 10.1016/S1470-2045(24)00402-9. Epub 2024 Sep 10.
PubMed 39270701
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03849118
- Acronym / sponsor ID
- 89ZR-TLX250 / 89Zr-TLX250-003
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- diagnostic, confirmatory, prospective, multi-centre
| Arm | Type | Receives |
|---|---|---|
| 89Zr-girentuximab | Experimental | Diagnostic Test: 89Zr-girentuximabA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-girentuximabAlso: 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days. | Diagnostic test | 89Zr-girentuximab |
Primary outcome
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.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40408016Chowdhury A, Morgat C, Bailly C, Sunderland J, Graves SA, Scott AM, Baker S, Holman BF. Radiation protection considerations with [89Zr]Zr-girentuximab PET and surgery. EJNMMI Res. 2025 May 23;15(1):59. doi: 10.1186/s13550-025-01247-1.
- Derived from this study: PubMed 39270701Shuch B, Pantuck AJ, Bernhard JC, Morris MA, Master V, Scott AM, van Praet C, Bailly C, Onal B, Aksoy T, Merkx R, Schuster DM, Lee ST, Pandit-Taskar N, Fan AC, Allman P, Schmidt K, Tauchmanova L, Wheatcroft M, Behrenbruch C, Hayward CRW, Mulders P. [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Oct;25(10):1277-1287. doi: 10.1016/S1470-2045(24)00402-9. Epub 2024 Sep 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Gurney, MD principal investigator
Macquarie University Hospital
Francoise Brodere, MD principal investigator
University Hospital ICO, Nantes, France
Peter Mulders, MD principal investigator
Radboud University Medical Center
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 89Zr-girentuximab in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, Turkey (Türkiye), Canada, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.