Trial record 18 of 122 for:    asthma | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Xemed LLC
Sponsor:
Collaborators:
University of Virginia
Washington University School of Medicine
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Information provided by (Responsible Party):
Xemed LLC
ClinicalTrials.gov Identifier:
NCT01833390
First received: April 1, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Asthma
COPD
Healthy
Drug: HXe MRI lung ventilation
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Xemed LLC:

Primary Outcome Measures:
  • HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients [ Time Frame: three years ] [ Designated as safety issue: No ]
    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 [ Time Frame: three years ] [ Designated as safety issue: No ]
    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 [ Time Frame: three years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 76
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HXe MRI lung ventilation
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.
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.
Other Names:
  • Hyperpolarized Xenon
  • MagniXene
  • HXe

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833390

Contacts
Contact: Iulian C Ruset, PhD 603-868-1888 ext 113 icruset@xemed.com
Contact: F.William Hersman, PhD 603-868-1888 ext 110 hersman@xemed.com

Locations
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63310
Contact: James Quirk, PhD    314-362-3875    quirkj@mir.wustl.edu   
Contact: Lora Gallagher, B.S.    314-747-4065    gallagher@wustl.edu   
Principal Investigator: James Quirk, PhD         
United States, Ohio
Cincinnati Children's Hospital in partnership with University Hospital of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jason C Woods, PhD    513-803-4463    jason.woods@cchmc.org   
Contact: Jennifer Jeffries, RN, CCRP    513-803-0062    jenny.jeffries@cchmc.org   
Principal Investigator: Jason C Woods, PhD         
Sub-Investigator: Kai Ruppert, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Talissa A Altes, M.D.    434-924-0211      
Contact: Joanne Gersbach, R.N.    434-243-6074    jcg4j@virginia.edu   
Principal Investigator: Talissa A Altes, M.D.         
Sub-Investigator: John P Mugler, III, PhD         
Sponsors and Collaborators
Xemed LLC
University of Virginia
Washington University School of Medicine
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Investigators
Principal Investigator: Talissa A Altes, M.D. University of Virginia
Principal Investigator: James Quirk, PhD Washington University School of Medicine
Principal Investigator: Iulian C Ruset, PhD Xemed LLC
Principal Investigator: Jason C Woods, PhD Cincinnati Children's Hospital and University Hospital of Cincinnati
  More Information

No publications provided

Responsible Party: Xemed LLC
ClinicalTrials.gov Identifier: NCT01833390     History of Changes
Other Study ID Numbers: MagniXene-087550-01, R44HL087550
Study First Received: April 1, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Xemed LLC:
Hyperpolarized Xenon
HXe
MagniXene

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014