使用 Gadoxetate Disodium 开发肝纤维化成像生物标志物
研究概览
详细说明
多种原因造成的肝损伤会导致一种称为肝纤维化的病症。 常见原因是长期饮酒和丙型肝炎感染。 该病可发展为肝硬化和肝功能衰竭,是美国第七大死因。 目前,活检仍然是测试所提出的各种治疗是否有效的唯一可靠方法,但活检的风险排除了频繁的重新评估。 因此,真正的个性化治疗因缺乏可以进行定期评估的非侵入性、低风险但适当合格的测试而受到阻碍。
2008 年 7 月,FDA 批准了一种名为 Eovist 的新药,它可以被肝细胞吸收,并且在进行 MRI 时可以在肝脏中看到。 Eovist 吸收的量和时间进程在健康和纤维化肝组织之间会有所不同。 我们相信,这些参数,结合血液学和免疫学血液测试,可以预测肝纤维化的程度,而不需要活检。 这将有助于改进对可能改变潜在疾病进程的潜在重要干预措施的评估。 因此,开发这种非侵入性生物标志物不仅可以避免活检的需要,而且还可以进行目前无法进行的更深入的定期评估。
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- 招聘中
- Weill Cornell Medical College
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接触:
- Ame Ng
- 电话号码:212-746-2194
- 邮箱:ameng@med.cornell.edu
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首席研究员:
- Krishna Juluru, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 计划在未来进行肝活检或在计划进行 MR 成像前 6 个月内进行肝活检的丙型肝炎受试者,或
- 健康、无肝病的受试者(用于正常对照)
所有关于性别、种族和族裔的亚群将有平等的机会被纳入研究方案。 研究方案仅包括与就诊时的年龄(>21 岁)一致的成年人群。
排除标准:
- 有任何使用静脉造影剂获得 MRI 禁忌症的受试者,包括:体内金属、严重肾功能不全、怀孕或母乳喂养。 将使用与为常规临床检查提供的相同的筛选问卷来确定禁忌症。
- 对 MRI 造影剂有过敏史的受试者
严重肾功能损害定义为肾小球滤过率 (GFR) < 30 mL/min/1.73 平方米。 所有受试者都将通过问卷进行筛选。 将在计划的 MRI 检查日期的 6 周内使用血液化学对报告肾脏问题或肾脏问题病史的任何受试者计算 GFR。 这些血液化学需要作为常规临床护理的一部分进行。 报告肾脏问题或肾脏问题病史但在 MRI 检查后 6 周内没有可用血液化学的潜在受试者将被排除在参与本研究之外。
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:肝功能正常
控制组。
受试者将获得肝脏 MRI。
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肝脏 MRI 静脉注射钆塞酸二钠
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实验性的:丙型肝炎
患有丙型肝炎的受试者。受试者将获得肝脏 MRI 和有限的肝脏 CT。
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肝脏 MRI 静脉注射钆塞酸二钠
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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血管内和间质隔室之间的转移常数 Ktrans。
大体时间:长达 3 年
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Ktrans 是在对 MRI 检查中的所有图像进行分析后获得的传递常数,并且是组织渗透性的量度。
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长达 3 年
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合作者和调查者
调查人员
- 首席研究员:Krishna Juluru, MD、Weill Medical College of Cornell University
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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肝脏核磁共振的临床试验
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Compedica IncProfessional Education and Research Institute招聘中
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University of Stellenbosch完全的
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Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
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The University of Texas Health Science Center,...Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive and Kidney...完全的
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development未知
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Oregon Health and Science University未知