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NCT04624490 | RECRUITING | Asthma

Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Sponsor:

Mario Castro, MD, MPH

Information provided by (Responsible Party):

Mario Castro, MD, MPH

Brief Summary:

The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

Condition or disease

Asthma

COPD

Interstitial Lung Disease

Cystic Fibrosis

Pulmonary Hypertension

Pulmonary Infection

Other Lung Disease

Intervention/treatment

Hyperpolarized Xe129

Phase

PHASE1

Detailed Description:

This is an unblinded, open-label study with \~160 subjects with diagnosed pulmonary disease and \~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (\~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.

Study Type : INTERVENTIONAL
Estimated Enrollment : 260 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Actual Study Start Date : 2020-11-02
Estimated Primary Completion Date : 2025-10-26
Estimated Study Completion Date : 2026-10-26

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • Healthy Volunteers
    • * Subject has no diagnosed pulmonary conditions
    • * Ability to read and understand English or Spanish
    • Subjects with Lung Disease
      • * Subject has a diagnosis of pulmonary dysfunction made by a physician
      • * No acute worsening of pulmonary function in the past 30 days
      • * Ability to read and understand English or Spanish
      Exclusion Criteria
      • * MRI is contraindicated based on responses to MRI screening questionnaire
      • * Subject is pregnant or lactating
      • * Subject does not fit into 129Xe vest coil used for MRI
      • * Subject cannot hold his/her breath for 15-16 seconds
      • * Subject deemed unlikely to be able to comply with instructions during imaging
      • * Oxygen saturation \<88% on room air or with supplemental oxygen
      • * Cognitive deficits that preclude ability to provide consent
      • * Institutionalization
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Location Details

NCT04624490

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160