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MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects (HXe-VENT)

Primary Purpose

Asthma, COPD, Healthy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HXe MRI lung ventilation
Sponsored by
Xemed LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring Hyperpolarized Xenon, HXe, MagniXene

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HXe MRI lung ventilation

Arm Description

Each subject will inhale a dose of HXe gas (up to one liter HXe) while lying inside an MRI scanner. A high-resolution 3D map of the lung spaces filled with HXe gas will be acquired during a short breath-hold. Additionally, proton MRI of the chest cavity will be recorded during the same breath-hold for registering the lung boundaries. All subjects will undergo Pulmonary Function Tests. Subjects suffering from obstructive lung disease will have Tc-99m DTPA lung scintigraphy performed for comparing with HXe images.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 1, 2013
Last Updated
March 10, 2015
Sponsor
Xemed LLC
Collaborators
University of Virginia, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01833390
Brief Title
MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xemed LLC
Collaborators
University of Virginia, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD, Healthy
Keywords
Hyperpolarized Xenon, HXe, MagniXene

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HXe MRI lung ventilation
Arm Type
Experimental
Arm Description
Each subject will inhale a dose of HXe gas (up to one liter HXe) while lying inside an MRI scanner. A high-resolution 3D map of the lung spaces filled with HXe gas will be acquired during a short breath-hold. Additionally, proton MRI of the chest cavity will be recorded during the same breath-hold for registering the lung boundaries. All subjects will undergo Pulmonary Function Tests. Subjects suffering from obstructive lung disease will have Tc-99m DTPA lung scintigraphy performed for comparing with HXe images.
Intervention Type
Drug
Intervention Name(s)
HXe MRI lung ventilation
Other Intervention Name(s)
Hyperpolarized Xenon, MagniXene, HXe
Intervention Description
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.
Primary Outcome Measure Information:
Title
HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients
Description
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.
Time Frame
three years
Secondary Outcome Measure Information:
Title
Ventilated volume of the lungs determined by HXe MRI
Description
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.
Time Frame
three years
Title
Number of ventilation defects in COPD and asthma patients
Description
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.
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talissa A Altes, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iulian C Ruset, PhD
Organizational Affiliation
Xemed LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

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

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