HXe-VENTStudy of Hyperpolarized Xenon (MagniXene) in Patients With Obstructive Pulmonary Diseases (Asthma and COPD) to Assess Regional Lung Function by Delineating Regions of Abnormal Lung Ventilation
HXe MRI lung ventilation
Bronchial Diseases+11
+ Chronic Disease
+ Hypersensitivity
Diagnostic Study
Summary
Study start date: September 1, 2011
Actual date on which the first participant was enrolled.HXe MRI provides a diversity of imaging techniques for interrogating pulmonary function and lung microstructure. The most mature of these techniques utilizes HXe spin-density MRI to depict regional lung ventilation. Prior work suggests that ventilation imaging has utility in all obstructive lung diseases. This is a Phase II clinical trial to assess HXe MRI capability of providing qualitative and quantitative clinical information regarding lung ventilation. Proton and xenon images will be acquired within single breath holds on 28 subjects per year, including healthy volunteers and patients with COPD and asthma. All studies will include repeat scans and Pulmonary Function Tests (PFT). Ventilation scans with Technetium-99m (Tc-99m) diethylene-triamine-pentaacetate (DTPA) aerosol scintigraphy will be acquired on lung patients. The primary goal of this aim is to validate the effectiveness of HXe ventilation MRI for delineating regions of normal and abnormal lung ventilation. To validate the regional depiction of ventilation, HXe MRI ventilation will be compared with nuclear medicine Tc-99m DTPA ventilation scintigraphy. The comparatively low spatial and temporal resolution of ventilation scintigraphy will limit this study to demonstrating only that HXe MRI ventilation is not inferior to the current clinical standard. Additionally, the concordance between measurements of the whole lung volume from both proton MRI and HXe MRI with PFT, the current clinical standard for lung volume measurement, will be assessed as a secondary outcome of the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.58 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria (healthy subjects): Currently feeling well without respiratory symptoms. No history of lung disease. Never personally smoked (defined as less 100 cigarettes in their lifetime). Inclusion Criteria (COPD subjects): Forced Expiratory Volume in 1 second (FEV1)<80% predicted OR FEV1 to Forced Vital Capacity (FVC) ratio <70% Smoking history >10 pack years Subjects should be at their clinical baseline on the day of imaging Subjects must be clinically stable in order to participate in the study Inclusion Criteria (asthma subjects): Greater than 10% increase in FEV1 30-50 minutes after administration of albuterol; Subjects should be at their clinical baseline on the day of imaging; Subjects must be clinically stable in order to participate in the study. Exclusion Criteria: Baseline oxygen requirement. Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging. FEV1 percent predicted less than 25%. Pregnancy or lactation. Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded. Chest circumference greater than that of the xenon MR coil. History of congenital cardiac disease, chronic renal failure, or cirrhosis. Inability to understand simple instructions or to hold still for approximately 10 seconds. History of respiratory infection within 2 weeks prior to the MR scan. History of heart attack, stroke and/or poorly controlled hypertension. Known hypersensitivity to albuterol or any of its components, or levalbuterol.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location