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临床试验/NCT01632696
NCT01632696终止早期 1 期

Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

Peregrine Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
发起方
入组人数
11
试验地点
1
主要终点
To estimate the intensity and distribution in critical and non-critical organs.

研究概览

简要总结

Tumor Imaging of I-124 PGN65 in Solid Tumors

详细描述

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

I-124 PGN650 for PET/CT

Experimental

干预措施: I-124 PGN650 for PET/CT (Drug)

结局指标

主要结局

To estimate the intensity and distribution in critical and non-critical organs.

时间窗: Day 3

次要结局

  • The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.(Day 1, Day 2 and Day 3)
  • Demonstrate the safety of tumor imaging in patients with solid cancers.(Day 1, Day 2 and Day 3)

研究者

发起方
Peregrine Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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