跳至主要内容
临床试验/NCT03764163
NCT03764163已完成早期 1 期

Image and Model Based Analysis of Lung Disease

Eric A. Hoffman2 个研究点 分布在 1 个国家目标入组 341 人开始时间: 1997年9月30日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
341
试验地点
2
主要终点
Normal lung aging assessed by CT imaging

研究概览

简要总结

The purpose of this research study is to develop CT scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams.

详细描述

Specifically, the investigators are interested in understanding the difference between the normal aging process and the events that lead to emphysema. Additionally, the investigators are interested in understanding the earliest signs (lung inflammation) of the disease process leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of which are described as "inflammatory lung diseases." The investigators will be using the data from this study to help define the normal values for the measured properties as well as deviation from normal values in smokers without defined lung disease and patients with inflammatory lung disease. The investigators believe that the analysis and scanning techniques being developed as part of this research will provide new and previously unavailable information on normal and diseased lungs so that ultimately the investigators can detect specific changes in the lungs due to a disease and measure any improvements in the anatomy and/or function of the pulmonary system after a patient has undergone treatment. This study involves research using X-Ray computed tomography (CT) scanner, which is similar to previous CT scanners but operates much faster and provides finer image detail.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20 cigarettes in their lifetime
  • Smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20 cigarettes) per day, normal smokers and mild to moderate Chronic Obstructive Pulmonary Disease (COPD)

排除标准

  • Allergies - no allergies to shellfish, eggs, iodine
  • Medications - no medications (except for birth control) for in the 'normal' category
  • No asthma - as self reported
  • BMI (Body Mass Index) - must not exceed 32 or 100kg of weight
  • No other radiology studies in the last 12 months
  • No metal in lung field - no metal from larynx to stomach
  • No known heart disease
  • No known kidney disease or diabetes
  • Must not be pregnant - subjects of childbearing potential with be given a urine pregnancy test

研究组 & 干预措施

Study Participants

Experimental

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

干预措施: Pulmonary Function Test (Diagnostic Test)

Study Participants

Experimental

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

干预措施: CT Scans (Diagnostic Test)

Study Participants

Experimental

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

干预措施: Questionnaires (Behavioral)

Study Participants

Experimental

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

干预措施: MRI (Diagnostic Test)

Study Participants

Experimental

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

干预措施: Xenon gas (Biological)

结局指标

主要结局

Normal lung aging assessed by CT imaging

时间窗: up to 10 years

Normal aging process of the lungs compared to common smoking related lung diseases.

次要结局

未报告次要终点

研究者

发起方
Eric A. Hoffman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eric A. Hoffman

Professor

University of Iowa

研究点 (2)

Loading locations...

相似试验

Image and Model Based Analysis of Lung Disease | 临床试验