Clinical trial NCT01833390: MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
COPD
Healthy
Keywords: Hyperpolarized Xenon
HXe
MagniXene
Lead sponsor: Xemed LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-04-16
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients
timeFrame: three years
Secondary outcomes:
measure: Ventilated volume of the lungs determined by HXe MRI
timeFrame: three years
measure: Number of ventilation defects in COPD and asthma patients
timeFrame: three years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Talissa A Altes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xemed LLC
name: Iulian C Ruset, PhD
role: PRINCIPAL_INVESTIGATOR
References: