Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
研究概览
简要总结
The purpose of this study is being done to determine whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments.
Participants will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyper-polarized 129 Xenon. The subjects will have this initial study prior to initiation of IPF therapies. Then the participants will have repeat studies at 3, 6 and 12 months following the initiation of therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Clinical diagnosis of IPF by confirmed by multidisciplinary diagnosis and naïve to treatment with an approved IPF therapy (either nintedanib or pirfenidone)
排除标准
- •Subject is less than 18 years old
- •Subjects who have been previously on either pirfenidone or nintedanib
- •MRI is contraindicated based on responses to MRI screening questionnaire
- •Subject is pregnant or lactating
- •Resting oxygen saturation on room air <90% on supplemental oxygen
- •Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- •Subject with ventricular cardiac arrhythmia in the past 30 days.
- •Subject has history of cardiac arrest within the last year
- •Subject does not fit into 129 Xenon vest coil used for MRI
- •Subject deemed unlikely to be able to comply with instructions during imaging
- •Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
- •Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
研究组 & 干预措施
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
干预措施: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment (Drug)
结局指标
主要结局
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
时间窗: Baseline, 3, 6, and 12 months following initiation of IPF therapy
RBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised.
次要结局
- Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)(Baseline, 3, 6, and 12 months following initiation of IPF therapy)
- Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)(Baseline, 3, 6, and 12 months following initiation of IPF therapy)
研究者
Bastiaan Driehuys
Professor of Medicine
Duke University