NL-OMON52858已完成3 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) - ZIRCON study
TELIX International Pty Ltd - Françoise Bruyère0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female >= 18 years of age
- •- Imaging evidence of a single indeterminate renal mass of <= 7 cm in largest
- •diameter (tumour stage cT1), on standard of care imaging, based on national
- •standards, not older than 90 days on Day 0, but performed before any screening
- •- Scheduled for lesion resection as part of regular diagnostic work-up within
- •90 days from planned 89Zr-TLX250 administration.
- •- Sufficient life expectancy to justify nephrectomy.
- •- Consent to practise highly effective contraception until a minimum of 42 days
- •after 89Zr-TLX250 administration.
排除标准
- •- A biopsy procedure only (rather than 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
- •89Zr-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
- •- Known hypersensitivity to girentuximab or DFO (desferoxamine)
- •- Renal insufficiency with GFR <= 45 mL/min/ 1.73 m²
研究者
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