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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 60
- 主要终点
- 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.
研究概览
简要总结
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
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.
时间窗: 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
次要结局
未报告次要终点