Clear Cell Renal Cell CarcinomaPhase 3NCT06750419
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
A Phase 3 study testing 89Zr-TLX250 PET/CT in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 8 sites in China.
Trial summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118) 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-TLX250 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesChina
- Study dates
- 6 Nov 2024to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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.
- Mainland Chinese male or female, aged ≥ 18 years.
- Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
- Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
- Sufficient life expectancy to justify nephrectomy.
- Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.
Who cannot join
- A biopsy procedure only (rather than partial or total nephrectomy) is 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.
- Multiple unilateral or bilateral IRM.
- Chemotherapy, radiotherapy, targeted therapy 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 IV administration of 89Zr-TLX250 and imaging).
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- 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 with the safety or compliance of the study subject, 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 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or desferoxamine (DFO).
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
- Vulnerable patients (e.g., being in detention).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Peng Du, +86 13611376873, dupeng9000@126.com
Peng Du, Prof
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Xiaolong Qi, +86 15158885167, 15158885167@163.com
Xiaolong Qi
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Hubei
Xiaoli Lan, +86 13886193262, HZSLXL@163.com
Xiaoli Lan
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai
Hongcheng Shi, +86 13681971579, shi.hongcheng@zs-hospital.sh.cn
Hongcheng Shi
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Shibiao Sang, +86 13962112507, golf131701@sina.com
Shibiao Sang
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin
Dong Dai, +86 18622000577, xiandao5502@163.com
Dong Dai
- Not yet recruiting
Affiliated Hospital Of Jiangnan University
Wuxi
Chunjing Yu, +86 15312238622, ycj_wxd1978@163.com
Chunjing Yu
- Not yet recruiting
Zhejiang Cancer Hospital
Zhejiang
Linfa Li, +86 13666670158, pet-ct001@163.com
Linfa Li
About this study
Official title: A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
Read the detailed description
This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care.
Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging.
The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. 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 imaging vendor.
For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery.
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 Magnetic Resonance Imaging [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.
The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months.
No interim analysis is planned for this study.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- 89Zr-TLX250 PET/CT
- Keywords
- 89Zr-DFO-girentuximab, 89Zr-girentuximab, 89Zr-DFO-TFP-GTX, Clear Cell Renal Cell Carcinoma (ccRCC), Indeterminate Renal Mass (IRM), ZIRCON-CP study, 89Zirconium-labelled girentuximab, 89Zr-TLX250
- 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-TLX250 PET/CTDrug
Also called 89Zr-DFO-girentuximab, 89Zr-girentuximab, 89Zr-DFO-TFP-GTX, 89Zirconium-labelled girentuximab
89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol.
89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm receiving the IP | Experimental | Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging.
Following pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken.
On Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET/CT scan of the abdomen will occur on visit Day 5 (±2 days post administration [p.a.]) with nephrectomy to be performed any time after the PET/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250. Receives: Drug: 89Zr-TLX250 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth
Evaluating this outcome involved using a PET/CT machine on all patients to determine the uptake of the Zr89 radiotracer within the renal lesion, which was then compared to the histological determination of the lesion type following resection
Measured: From Visit 4 till end of study. 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
Secondary outcomes (5)
To determine the 89Zr-TLX250's test performance
Determine the Standardized Uptake Value (SUV) in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Measured: Day of Imaging (Day 5±2 post- IP administration).
To determine the 89Zr-TLX250's test performance
Determine the predictive values (%) of 89Zr-TLX250 PET/CT in detecting ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Measured: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To determine the 89Zr-TLX250's test performance
Evaluate the diagnostic accuracy (%) of 89Zr-TLX250 PET/CT in distinguishing ccRCC from non-ccRCC in the kidney in the Chinese patient population.
Measured: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To assess the safety and tolerability of 89Zr-TLX250
Number of AEs, incidence of anti-drug antibody detection following use of the study drug in Chinese patients with IRM
Measured: Day of IP administration (Day 0), Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28-90 days post-IP administration)
To evaluate the impact of 89Zr-TLX250 PET/CT on clinical decision-making as a diagnostic tool
Proportion of participants with changes in management plans based on PET/CT scan findings versus conventional imaging following the use of 89Zr-TLX250
Measured: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)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
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750419
- Sponsor's protocol ID
- TLX250CDx-CP-002
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers as it is in line with ICH-GCP guidelines, which emphasise the protection of participant confidentiality and the integrity of the study data. Additionally, sharing of IPD is not planned to ensure compliance with regulatory requirements and to maintain the proprietary nature of the data.
Publications
Shuch 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 392707012010 年第 7 版肾癌新分期的应用效果评估
肾包膜侵犯状况对于 肾癌临床症状及分期的意义
ZIRDOSE. An open-label, Phase I study to assess safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labelled girentuximab (89Zr-girentuximab) for in vivo detection of clear cell renal carcinoma (CCRC) by positron emission tomography (PET) using different PET imaging methodologies. ClinicalTrials.gov: NCT03556046
ZIRDAC-JP. Phase 1 open-label study to evaluate the safety/tolerability/radioactivity distribution of positron emission tomography (PET/CT) imaging with 89Zr-girentuximab (89Zr-TLX250) as well as to investigate its pharmacokinetics and pharmacodynamics in subjects with renal cell carcinoma including clear cell renal cell carcinoma (ZIRDAC-JP). ClinicalTrials.gov : NCT04496089
ZIRCON. A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study). ClinicalTrials.gov: NCT03849118
Wang HY, Ding HJ, Chen JH, Chao CH, Lu YY, Lin WY, Kao CH. Meta-analysis of the diagnostic performance of [18F]FDG-PET and PET/CT in renal cell carcinoma. Cancer Imaging. 2012 Oct 26;12(3):464-74. doi: 10.1102/1470-7330.2012.0042.
PubMed 23108238van Asselt SJ, Oosting SF, Brouwers AH, Bongaerts AH, de Jong JR, Lub-de Hooge MN, Oude Munnink TH, Fiebrich HB, Sluiter WJ, Links TP, Walenkamp AM, de Vries EG. Everolimus Reduces (89)Zr-Bevacizumab Tumor Uptake in Patients with Neuroendocrine Tumors. J Nucl Med. 2014 Jul;55(7):1087-92. doi: 10.2967/jnumed.113.129056. Epub 2014 May 1.
PubMed 24790218US FDA Guidance for Industry: Multiple Endpoints in Clinical Trials January 2017 (draft) https://www.fda.gov/media/102657/download
Stillebroer AB, Franssen GM, Mulders PF, Oyen WJ, van Dongen GA, Laverman P, Oosterwijk E, Boerman OC. ImmunoPET imaging of renal cell carcinoma with (124)I- and (89)Zr-labeled anti-CAIX monoclonal antibody cG250 in mice. Cancer Biother Radiopharm. 2013 Sep;28(7):510-5. doi: 10.1089/cbr.2013.1487. Epub 2013 May 22.
PubMed 23697926Stillebroer AB, Boerman OC, Desar IM, Boers-Sonderen MJ, van Herpen CM, Langenhuijsen JF, Smith-Jones PM, Oosterwijk E, Oyen WJ, Mulders PF. Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma. Eur Urol. 2013 Sep;64(3):478-85. doi: 10.1016/j.eururo.2012.08.024. Epub 2012 Aug 21.
PubMed 22980441Steffens MG, Boerman OC, de Mulder PH, Oyen WJ, Buijs WC, Witjes JA, van den Broek WJ, Oosterwijk-Wakka JC, Debruyne FM, Corstens FH, Oosterwijk E. Phase I radioimmunotherapy of metastatic renal cell carcinoma with 131I-labeled chimeric monoclonal antibody G250. Clin Cancer Res. 1999 Oct;5(10 Suppl):3268s-3274s.
PubMed 10541374Steffens MG, Kranenborg MH, Boerman OC, Zegwaart-Hagemeier NE, Debruyne FM, Corstens FH, Oosterwijk E. Tumor retention of 186Re-MAG3, 111In-DTPA and 125I labeled monoclonal antibody G250 in nude mice with renal cell carcinoma xenografts. Cancer Biother Radiopharm. 1998 Apr;13(2):133-9. doi: 10.1089/cbr.1998.13.133.
PubMed 10850349Steffens MG, Boerman OC, Oosterwijk-Wakka JC, Oosterhof GO, Witjes JA, Koenders EB, Oyen WJ, Buijs WC, Debruyne FM, Corstens FH, Oosterwijk E. Targeting of renal cell carcinoma with iodine-131-labeled chimeric monoclonal antibody G250. J Clin Oncol. 1997 Apr;15(4):1529-37. doi: 10.1200/JCO.1997.15.4.1529.
PubMed 9193349Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 2005 Jun;46(6):1023-7.
PubMed 15937315
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)
- ClinicalTrials.gov ID
- NCT06750419
- Acronym / sponsor ID
- TLX250CDx-CP-002
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- 89Zr-DFO-girentuximab, 89Zr-girentuximab, 89Zr-DFO-TFP-GTX, Clear Cell Renal Cell Carcinoma (ccRCC), Indeterminate Renal Mass (IRM), ZIRCON-CP study, 89Zirconium-labelled girentuximab, 89Zr-TLX250
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
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, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
Detailed description
This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care.
Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging.
The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. 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 imaging vendor.
For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery.
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 Magnetic Resonance Imaging [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.
The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months.
No interim analysis is planned for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm receiving the IP | Experimental | Drug: 89Zr-TLX250 PET/CTApproximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. Following pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken. On Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET/CT scan of the abdomen will occur on visit Day 5 (±2 days post administration [p.a.]) with nephrectomy to be performed any time after the PET/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written and voluntarily given informed consent.
- Mainland Chinese male or female, aged ≥ 18 years.
- Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
- Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
Key exclusion criteria (15 listed)
- A biopsy procedure only (rather than partial or total nephrectomy) is 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.
- Multiple unilateral or bilateral IRM.
- Chemotherapy, radiotherapy, targeted therapy 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).
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-TLX250 PET/CTAlso: 89Zr-DFO-girentuximab, 89Zr-girentuximab, 89Zr-DFO-TFP-GTX, 89Zirconium-labelled girentuximab89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol. 89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose. | Drug | Experimental arm receiving the IP |
Primary outcome
To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth
Time frame: From Visit 4 till end of study. 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
Evaluating this outcome involved using a PET/CT machine on all patients to determine the uptake of the Zr89 radiotracer within the renal lesion, which was then compared to the histological determination of the lesion type following resection
5 secondary outcomes
To determine the 89Zr-TLX250's test performance
Time frame: Day of Imaging (Day 5±2 post- IP administration).
To determine the 89Zr-TLX250's test performance
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To determine the 89Zr-TLX250's test performance
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
To assess the safety and tolerability of 89Zr-TLX250
Time frame: Day of IP administration (Day 0), Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28-90 days post-IP administration)
To evaluate the impact of 89Zr-TLX250 PET/CT on clinical decision-making as a diagnostic tool
Time frame: Day of Imaging (Day 5±2 post- IP administration), Post-Imaging study visit (Day 42±7 post- IP administration), Day of surgery (within 28 days post-IP administration) or Day of surgery (28 to 90 days post-IP administration).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: 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.
- Background2010 年第 7 版肾癌新分期的应用效果评估
- Background肾包膜侵犯状况对于 肾癌临床症状及分期的意义
- BackgroundZIRDOSE. An open-label, Phase I study to assess safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labelled girentuximab (89Zr-girentuximab) for in vivo detection of clear cell renal carcinoma (CCRC) by positron emission tomography (PET) using different PET imaging methodologies. ClinicalTrials.gov: NCT03556046
- BackgroundZIRDAC-JP. Phase 1 open-label study to evaluate the safety/tolerability/radioactivity distribution of positron emission tomography (PET/CT) imaging with 89Zr-girentuximab (89Zr-TLX250) as well as to investigate its pharmacokinetics and pharmacodynamics in subjects with renal cell carcinoma including clear cell renal cell carcinoma (ZIRDAC-JP). ClinicalTrials.gov : NCT04496089
- BackgroundZIRCON. A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study). ClinicalTrials.gov: NCT03849118
- Background: PubMed 23108238Wang HY, Ding HJ, Chen JH, Chao CH, Lu YY, Lin WY, Kao CH. Meta-analysis of the diagnostic performance of [18F]FDG-PET and PET/CT in renal cell carcinoma. Cancer Imaging. 2012 Oct 26;12(3):464-74. doi: 10.1102/1470-7330.2012.0042.
- Background: PubMed 24790218van Asselt SJ, Oosting SF, Brouwers AH, Bongaerts AH, de Jong JR, Lub-de Hooge MN, Oude Munnink TH, Fiebrich HB, Sluiter WJ, Links TP, Walenkamp AM, de Vries EG. Everolimus Reduces (89)Zr-Bevacizumab Tumor Uptake in Patients with Neuroendocrine Tumors. J Nucl Med. 2014 Jul;55(7):1087-92. doi: 10.2967/jnumed.113.129056. Epub 2014 May 1.
- BackgroundUS FDA Guidance for Industry: Multiple Endpoints in Clinical Trials January 2017 (draft) https://www.fda.gov/media/102657/download
- Background: PubMed 23697926Stillebroer AB, Franssen GM, Mulders PF, Oyen WJ, van Dongen GA, Laverman P, Oosterwijk E, Boerman OC. ImmunoPET imaging of renal cell carcinoma with (124)I- and (89)Zr-labeled anti-CAIX monoclonal antibody cG250 in mice. Cancer Biother Radiopharm. 2013 Sep;28(7):510-5. doi: 10.1089/cbr.2013.1487. Epub 2013 May 22.
- Background: PubMed 22980441Stillebroer AB, Boerman OC, Desar IM, Boers-Sonderen MJ, van Herpen CM, Langenhuijsen JF, Smith-Jones PM, Oosterwijk E, Oyen WJ, Mulders PF. Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma. Eur Urol. 2013 Sep;64(3):478-85. doi: 10.1016/j.eururo.2012.08.024. Epub 2012 Aug 21.
- Background: PubMed 10541374Steffens MG, Boerman OC, de Mulder PH, Oyen WJ, Buijs WC, Witjes JA, van den Broek WJ, Oosterwijk-Wakka JC, Debruyne FM, Corstens FH, Oosterwijk E. Phase I radioimmunotherapy of metastatic renal cell carcinoma with 131I-labeled chimeric monoclonal antibody G250. Clin Cancer Res. 1999 Oct;5(10 Suppl):3268s-3274s.
- IPD registration in Chinadrugtrials as per Chinese requirementsLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers as it is in line with ICH-GCP guidelines, which emphasise the protection of participant confidentiality and the integrity of the study data. Additionally, sharing of IPD is not planned to ensure compliance with regulatory requirements and to maintain the proprietary nature of the data.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 89Zr-TLX250 PET/CT in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 8 sites in China.
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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily Nahidi (+61 3909 33871, lily.nahidi@telixpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth (time frame: From Visit 4 till end of study. 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 NCT06750419, which also lists 44 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 27 Dec 2024.