EUCTR2018-002773-21-GB进行中（未招募）1 期
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) - 89Zr-TLX250 for PET/CT imaging of ccRCC (ZIRCON-study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •All patients must meet all of the following 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 = 7 cm in largest diameter (tumour stage cT1), on MRI or equivalent standard of care imaging, with contrast agent, not older than 90 days on Day 0, but performed before any screening procedure, 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 confirmation of negative pregnancy test result from urine 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 practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •A patient will be excluded from participation in the trial if one or more of the following criteria are met:
- •1. A bioptic procedure only (rather than 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 89Zr-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 with the safety or compliance of the subject, 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 (desferoxamine)
- •13. Renal insufficiency with GFR = 60 mL/min/ 1.73 m²
- •14. Vulnerable patients (e.g. being in detention)
研究者
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