NCT01762592撤回3 期
A Study of Iodine (124I) Girentuximab PET/CT Scan for the Detection of Clear Cell Renal Cell Carcinoma in Patients With Indeterminate cT1 Renal Masses
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.
研究概览
简要总结
Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.
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
- •≥18 years of age.
- •Presence of indeterminate cT1 renal mass by screening CT with and without contrast or MRI with and without contrast (MRI only if CT is contra-indicated).
- •Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
- •Recovered from toxicity of any prior therapy to grade 1 or better.
- •Able to take oral medication (KI).
- •Written informed consent available.
排除标准
- •Renal mass known to be a metastasis of another primary tumor.
- •Known histology of renal mass (e.g. by biopsy).
- •Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
- •Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (>grade 1) from such therapy.
- •Exposure to murine proteins or chimeric antibodies within the last 5 years.
- •Intercurrent medical condition that may limit patient's study participation or compliance.
- •History of autoimmune hepatitis.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
- •Women who are pregnant or breastfeeding.
- •Contraindication to KI intake (see package insert/Appendix VI).
- •Hyperthyroidism, or Grave's Disease.
- •Contraindication for PET/CT.
研究组 & 干预措施
Iodine (124I) Girentuximab
Experimental
Single infusion of radio labeled antibody: 30 mL will be infused using an infusion pump at a rate of 2mL/min over 15 minutes on study day 0.
干预措施: Iodine (124I) Girentuximab (Drug)
结局指标
主要结局
Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.
时间窗: PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.
次要结局
未报告次要终点
研究者
研究点 (8)
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