NCT04833959撤回1 期
Pilot Study of 89Zr Panitumumab in Pancreas Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events assessed by CTCAE v5
研究概览
简要总结
The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of pancreatic cancer.
排除标准
- •Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- •History of infusion reactions to monoclonal antibody therapies.
- •Pregnant or breastfeeding.
- •Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- •Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- •Severe renal disease or anuria.
- •Known hypersensitivity to deferoxamine or any of its components.
研究组 & 干预措施
89Zr-Panitumumab
Experimental
Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection.
干预措施: 89Zr-panitumumab (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events assessed by CTCAE v5
时间窗: 7 days
Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type.
次要结局
未报告次要终点
研究者
研究点 (1)
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