ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 101 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03455686
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Parameswaran Nair, McMaster University

Brief Summary:
This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Bronchiectasis Emphysema Pulmonary Fibrosis Bronchopulmonary Dysplasia Alpha 1-Antitrypsin Deficiency Sarcoidosis, Pulmonary Other: Hyperpolarized 129Xe MRI Not Applicable

Detailed Description:

The primary objective of this study is to evaluate the ventilation defect percent (VDP), apparent diffusion coefficient (ADC) and/or the signal-to-noise ratio (SNR) obtained by analysis of hyperpolarized 129Xe MRI at one or more time-points (over time in the absence of therapeutic intervention or following clinically indicated therapy) in healthy volunteers and patients with lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.

This will be a single centre exploratory study in 10 healthy volunteers with normal lung function and no history of lung disease and 50 patients with a clinical diagnosis of lung disease. There is one study visit required for participation. A subset of participants may be asked to return for up to five additional study visits per year for five years. The purpose of additional study visits is to understand how hyperpolarized 129Xe MRI measurements of lung structure and function change over time in the absence of therapeutic intervention or following clinically indicated therapy.

All subjects will visit St Joseph's Healthcare Hamilton and undergo: vital signs, pulmonary function testing, questionnaires, proton (1H) MRI, static ventilation and/or diffusion-weighted 129Xe MRI, and sputum induction. Up to four doses of hyperpolarized 129Xe will be inhaled during a single study visit.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single-centre Study Exploring the Utility of Hyperpolarized 129Xe Magnetic Resonance Imaging in Healthy Volunteers and Patients With Lung Disease
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Patients with and without lung disease
All enrolled patients will undergo pulmonary function testing, questionnaires, 1H MRI, static ventilation and/or diffusion-weighted hyperpolarized 129Xe MRI and sputum induction at one or more timepoints over five years.
Other: Hyperpolarized 129Xe MRI
Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas is a research approach for the non-invasive visualization and measurement of lung structure and function.




Primary Outcome Measures :
  1. Ventilation Defect Percent (VDP) [ Time Frame: 1-5 years ]
    Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.

  2. Apparent Diffusion Coefficient (ADC) [ Time Frame: 1-5 years ]
    Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.


Secondary Outcome Measures :
  1. Signal-to-noise ratio (SNR) [ Time Frame: 1-5 years ]
    Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for participants with lung disease:

  • Male or female aged 18-85 years with diagnosed lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.
  • Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Able to read and/or understand English
  • Have a diagnosis of lung disease

Inclusion Criteria for healthy volunteers:

  • Subjects male or female aged 18-85 years
  • Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Able to read and/or understand English
  • No current or previous history of respiratory infection or disease

Exclusion Criteria:

  • Age < 18 years or >85 years
  • Pregnancy prior to or during study
  • In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
  • Patient is unable to perform spirometry or plethysmography maneuvers
  • Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist/3T Manager)
  • In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia

Exclusion Criteria for healthy volunteers only:

  • Current or previous history of respiratory infection or disease
  • Current smoker or ex-smoker with ≥10 pack-year history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455686


Contacts
Contact: Sarah Svenningsen, PhD (905) 522-1155 ext 37313 svennins@mcmaster.ca
Contact: Melanie Kjarsgaard, RRT (905) 522-1155 ext 33024 mkjarsga@stjosham.on.ca

Locations
Canada, Ontario
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Sarah Svenningsen, PhD    905-522-1155 ext 37313    svennins@mcmaster.ca   
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Parameswaran Nair, MD, PhD McMaster University

Publications:

Responsible Party: Parameswaran Nair, Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT03455686     History of Changes
Other Study ID Numbers: FIRH_Xe0001
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parameswaran Nair, McMaster University:
magnetic resonance imaging
hyperpolarized xenon-129
lung function
lung structure

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Subcutaneous Emphysema
Lung Diseases, Interstitial
Pulmonary Fibrosis
Sarcoidosis
Bronchiectasis
Bronchopulmonary Dysplasia
Alpha 1-Antitrypsin Deficiency
Sarcoidosis, Pulmonary
Respiratory Tract Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Bronchial Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn