MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects

Healthy Clinical Trial

— HXe-VENT  

Official title:

Study 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833390
• Other study ID #: MagniXene-087550-01
• Secondary ID: R44HL087550
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2013
• Last updated: March 10, 2015
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Xemed LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• COPD
• Healthy

Intervention

Drug:
• HXe MRI lung ventilation
MagniXene (HXe) is an Investigational New Drug made of xenon noble gas. Through a physical process using alkali vapors and powerful lasers, xenon atoms have their nuclear spin preferentially aligned (hyperpolarized), thus offering a highly enhanced signal inside an MRI scanner. High-resolution images of the lung spaces are acquired within a short breath-hold after inhalation of HXe.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Xemed LLC	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients	Depiction of ventilation defects with HXe MRI is not worse than presently accepted clinical method, Tc-99m DTPA scintigraphy, as judged by skilled readers and software analysis. The primary outcome variable will be binary: if ventilation is detected the value is 1, the value is 0 otherwise (defect). The level of agreement between HXe MRI and Tc-99m DTPA will be statistically calculated.	three years	No
Secondary	Ventilated volume of the lungs determined by HXe MRI	A secondary outcome will be HXe MRI capability of describing parameters of the lung physiology, such as the ventilated volume of the lungs as compared to that extracted from imaging the pleural cavity via proton MRI for healthy subjects and from the pulmonary function tests for lung disease patients.	three years	No
Secondary	Number of ventilation defects in COPD and asthma patients	The agreement between the number of ventilation defects as determined by skilled readers from HXe MRI and Tc-99m DTPA scintigraphy will be studied based on an extension of the Bland Altman statistical method for repeated measures data.	three years	No