Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors
2016年9月8日 更新者:Mallinckrodt
An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.
研究概览
研究类型
介入性
注册 (实际的)
150
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Florida
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Miami、Florida、美国、33136
- University of Miami, Jackson Memorial Hospital
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Medical Center
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Louisiana
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New Orleans、Louisiana、美国、70112
- Louisiana State University, Division of Hem/Onc
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of University of Pennsylvania, Division of Nuclear Medicine
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males or females 18 years of age and older.
- If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
- If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
- Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
- Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
- Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
- Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
- Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.
Exclusion Criteria:
- Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
- Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
- Patients who are pregnant, breastfeeding or lactating.
- Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:阶乘赋值
- 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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实验性的:Group 1
Control, age greater than or equal to 18 with normal renal function
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 2
Age 18 to less than 65 with mild renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 3
Age 18 to less than 65 with moderate to severe renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 4
Age 18 to less than 65 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 5
Age 65 to less than 75 with mild renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 6
Age 65 to less than 75 with moderate to severe renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 7
Age 65 to less than 75 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 8
Age greater than or equal to 75 with mild renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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实验性的:Group 10
Age greater than or equal to 75 with end stage renal impairment
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Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
大体时间:Through 24 hours post dose
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Through 24 hours post dose
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis
大体时间:Through 24 hours post dose
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Through 24 hours post dose
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年7月1日
初级完成 (实际的)
2005年8月1日
研究完成 (实际的)
2005年8月1日
研究注册日期
首次提交
2009年7月21日
首先提交符合 QC 标准的
2009年7月22日
首次发布 (估计)
2009年7月23日
研究记录更新
最后更新发布 (估计)
2016年9月9日
上次提交的符合 QC 标准的更新
2016年9月8日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.