Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Efficacy of 19F MRI compared to 133 Xenon Scintigraphy
研究概览
简要总结
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
详细描述
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
- •Outpatients of either gender, age >
- •Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- •Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- •Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).
排除标准
- •Subjects presenting with any of the following will not be included in the trial:
- •Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
结局指标
主要结局
Efficacy of 19F MRI compared to 133 Xenon Scintigraphy
时间窗: 24 months
To evaluate the non-inferiority of 19F Perfluorinated gas MRI compared to 133 Xenon Scintigraphy ventilation imaging studies two readers will be selected as having experience reading Xe-133 ventilation scans. Readers will also receive training on interpretation of 19F ventilation images We note that the nature of the images both nuclear medicine and 19F MRI preclude blinding of the readers to the image modality. Images from each modality will be assessed independently and the images will be coded so that readers will not know which image set is from each subject.
次要结局
未报告次要终点
研究者
Hal C Charles
Assistant Professor of Radiology
Duke University