Completed

HXe-VENTStudy 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

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What is being tested

HXe MRI lung ventilation

Drug
Who is being recruted

Bronchial Diseases+11

+ Chronic Disease

+ Hypersensitivity

From 21 to 75 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorXemed LLC
Last updated: March 11, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01833390
Principal SponsorXemed LLC
Last updated: March 11, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory HypersensitivityRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesAsthmaPulmonary Disease, Chronic Obstructive

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Virginia

Charlottesville, United StatesOpen University of Virginia in Google Maps
CompletedOne Study Center