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

NCT01833390 | Completed Phase 2

• 2 other identifiers: MagniXene-087550-01R44HL087550
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD; Healthy

Keywords

Hyperpolarized Xenon; HXe; MagniXene

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Ventilated volume of the lungs determined by HXe MRI

  three years

• Number of ventilation defects in COPD and asthma patients

  three years

Study Arms (1)

HXe MRI lung ventilation

EXPERIMENTAL

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

Interventions

HXe MRI lung ventilation 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.

Also known as: Hyperpolarized Xenon, MagniXene, HXe

HXe MRI lung ventilation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xemed LLC: lead
• University of Virginia: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Talissa A Altes, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Iulian C Ruset, PhD

  Xemed LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 16, 2013
• Study Start: September 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-02

Locations

US (1)