129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
研究概览
简要总结
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.
详细描述
This study focuses on the markers that are derived from the interaction of 129Xe with pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift.
In addition to healthy volunteers, the population to be studied will consist of patients scheduled to undergo either transfusion or phlebotomy, those with dyspnea, those with a physician diagnosis of interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •for Healthy Volunteers:
- •(Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)
- •Outpatients of either gender, age > 18
- •Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)
- •Subject has no diagnosed pulmonary conditions
- •Subject has not smoked in the previous 5 years
- •Smoking history, if any, is less than or equal to 5 pack-years
- •No history of using other inhaled products more than 1/week for > 1 year
- •Inclusion Criteria for Transfusion and Phlebotomy Patients:
- •In-patient or outpatients of either sex, age > 18
- •Willing and able to give informed consent and adhere to visit/protocol
- •And one of the following:
- •Patients who are scheduled to receive a red cell transfusion for anemia.
- •Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
- •Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)
- •Inclusion Criteria for Oxygen Administration Patients:
- •In-patient or outpatients of either sex, age > 18
- •Willing and able to give informed consent and adhere to visit/protocol
- •And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):
- •Interstitial Lung Disease or Dyspnea
- •Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea
- •Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- •Patients with a diagnosis of CTEPH, defined as mean PA pressure >20 mmHg with a pulmonary vascular resistance >2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- •Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
- •Healthy Volunteer (criteria noted above)
- •Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:
- •In-patient or outpatients of either sex, age > 18
- •Willing and able to give informed consent and adhere to visit/protocol
- •And one of the following categories (Acute or Chronic)
- •Acute Pulmonary Embolism
- •Patients presenting with acute PE 24-48hrs post-admission
- •Willing to return after 3-6 months of anti-coagulation therapy
- •Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- •Patients with a diagnosis of CTEPH, defined as mean PA pressure >20 mmHg with a pulmonary vascular resistance >2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- •Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
排除标准
- •for All subjects:
- •Subjects presenting with any of the following will not be included in the trial:
- •MRI is contraindicated based on responses to MRI screening questionnaire
- •Subject is pregnant or lactating
- •Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- •Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- •Subject has history of any known ventricular cardiac arrhythmia
- •Subject has history of cardiac arrest within the last year
- •Subject does not fit into 129Xe vest coil used for MRI
- •Subject cannot hold his/her breath for 10 seconds
- •Subject deemed unlikely to be able to comply with instructions during imaging
- •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
Transfusion and Phlebotomy Patients
Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
干预措施: Hyperpolarized Xe129 (Drug)
Oxygen Administration Patients
Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.
干预措施: Hyperpolarized Xe129 (Drug)
Oxygen Administration Patients
Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.
干预措施: Oxygen Administration (Other)
Acute or Chronic Pulmonary Embolism Patients
Individuals recently diagnosed with a blood clot in their lungs.
干预措施: Hyperpolarized Xe129 (Drug)
结局指标
主要结局
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
时间窗: Up to 5 days pre/post transfusion or apheresis
The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
时间窗: Baseline, 1 day
To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Change in RBC Oscillation Amplitude Post Therapy
时间窗: Baseline, 3-6 months post-treatment
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
次要结局
未报告次要终点
研究者
Bastiaan Driehuys
Professor of Radiology
Duke University