Radiation Dose in Humans From Orally Administered Tc99m-Heparin
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Biodistribution of Tc99m-heparin
研究概览
简要总结
This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil).
The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population
- •7 controls (subjects without GI symptoms and known GI disease)
排除标准
- •bleeding diathesis or contraindication to esophageal biopsies
- •severe sleep apnea
- •incarceration
- •pregnancy
- •inability to lie flat for 2 hours
- •history of bleeding disorder
- •Use of steroids
- •Breast feeding
- •Allergy to heparin or history of severe reaction to heparin
- •allergy to mucomyst or severe asthma
研究组 & 干预措施
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
干预措施: Computerized Tomography scan (Radiation)
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
干预措施: Single Photon Emission Computed Tomography scans (Radiation)
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
干预措施: Technetium Tc 99M (Drug)
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
干预措施: Planar Images (Radiation)
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
干预措施: Esophagogastroduodenoscopy (Procedure)
Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
干预措施: Computerized Tomography scan (Radiation)
Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
干预措施: Single Photon Emission Computed Tomography scans (Radiation)
Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
干预措施: Technetium Tc 99M (Drug)
Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
干预措施: Planar Images (Radiation)
Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
干预措施: Esophagogastroduodenoscopy (Procedure)
结局指标
主要结局
Biodistribution of Tc99m-heparin
时间窗: over approximately 24-26 hours
Biodistribution of Tc99m-heparin to the esophagus and other organs, especially of the gastrointestinal tract as judged by planar scans and by single photon emission computed tomography scans.
Calculation of organ doses
时间窗: over approximately 24-26 hours
Calculation of organ doses from the oral administration of Tc99m-heparin. The organ doses will be measured in miliSieverts using a computer program called OLINDA (Version 2).
次要结局
未报告次要终点
研究者
Gerald J. Gleich
Principal Investigator
University of Utah