NCT03764137撤回1 期
Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Image Quality
研究概览
简要总结
This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.
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
- •Be at least 19 years of age.
- •Diagnosis of colon cancer
- •Scheduled to undergo surgical resection
排除标准
- •Inability to provide informed consent
- •Pregnancy
- •Inability to lie still for the imaging study
- •Weight over 350 lbs., due to the scanner bore size
- •Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- •Inability to receive Omnipaque (iohexol) iodinated contrast
- •Inability to receive glucagon
- •Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent
- •Allergy to contrast imaging agents
- •Finding or suspicion of distant metastases on CT
研究组 & 干预措施
[89Zr]Panitumumab-PET/MRI patients
Experimental
All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.
干预措施: [89Zr]Panitumumab PET-MRI (Drug)
结局指标
主要结局
Image Quality
时间窗: 12 months
Diagnostic image quality of \[89Zr\]Panitumumab PET imaging in patients with newly diagnosed colon cancer with nodal involvement. Standardized Uptake Values (SUVs) will be measured.
次要结局
未报告次要终点
研究者
Suzanne E. Lapi, PhD
Director Cyclotron Facility
University of Alabama at Birmingham
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