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

NCT ID: NCT01833390

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Asthma; COPD; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HXe MRI lung ventilation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Hyperpolarized Xenon; MagniXene; HXe

Eligibility Criteria

Inclusion Criteria

• Currently feeling well without respiratory symptoms.
• No history of lung disease.
• Never personally smoked (defined as less 100 cigarettes in their lifetime).

• 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Xemed LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Talissa A Altes, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Iulian C Ruset, PhD

Role: PRINCIPAL_INVESTIGATOR

Xemed LLC

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

R44HL087550

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MagniXene-087550-01

Identifier Type: -

Identifier Source: org_study_id