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Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences (PULMOREM)

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ClinicalTrials.gov Identifier: NCT02786056
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in regional lung ventilation. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Other: Lung MRI examination Not Applicable

Detailed Description:
Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. severe structural alterations in the airways and parenchyma, such as bronchiectasis, mucus plugging, air trapping and infiltrations. These in turn result in focal or heterogeneous abnormalities in regional lung ventilation. End-stage lung disease remains the main cause of morbidity and mortality in CF patients. Currently, new targeted CFTR correctors and potentiators are under trial. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients, and for the assessment of targeted therapeutic interventions. Computed tomography (CT) is considered as the technology of choice for lung imaging in CF. However, CT requires exposure to significant ionizing radiation, which is a major concern in the pediatric population because children are more radiosensitive than adults and there is an increased risk of radiation-induced cancer from the cumulative dose related to repeated CT investigations. Recent improvements in magnetic resonance imaging (MRI) technology offer a non-ionizing alternative to CT for imaging the lung parenchyma. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers. If the regional changes in proton density in the lung parenchyma during the respiratory cycle prove to be measurable in healthy volunteers, then MRI can be used to quantify regional lung ventilation. This would offer a unique non-invasive, radiation- and contrast media-free alternative to CT for phenotyping and follow-up of CF patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences (PULMOREM Study)
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lung MRI examination Other: Lung MRI examination
Lung MRI examination is performed for approximately 30 min on a 3T machine (Achieva 3T, Philips) using UTE sequences, both during free breathing with image synchronisation using an echo-navigator, and during an end-inspiratory and end-expiratory pauses. In the 10 first subjects, the MR protocol is optimized in order to maximize MRI parenchymal signal intensity, signal-to-noise ratio and contrast-to-noise ratio. The final image acquisition parameters will be applied in the following 30 subjects in order to assess the outcomes of the study.




Primary Outcome Measures :
  1. Correlation between the magnitude of change in MRI signal intensity from end-inspiration to end-expiration, averaged over the entire 3D lung image, and tidal volume measured by spirometry during imaging [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Agreement between the correlation coefficient of MRI signal intensity change vs. tidal volume acquired during free breathing, and that acquired in static conditions (end-inspiration, end-expiration) [ Time Frame: 30 days ]
  2. Comparison of signal-to-noise and contrast-to-noise ratio of lung parenchyma measured using UTE MRI to values published in the litterature. [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subject aged 18 to 65 years.
  • Written informed consent.
  • Health insurance policy holder.

Exclusion Criteria:

  • Current smoker
  • Detained or legally irresponsable.
  • No social security or health insurance policy.
  • Chronic respiratory diseases (such as asthma, COPD, CF, pulmonary fibrosis or hypertension).
  • Acute or recent lower respiratory tract infection.
  • Smoking or heavy meal less than 1 hour prior to imaging.
  • Acute or recent serious health condition (such as : myocardial infarction, pulmonary embolism…).
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, metallic ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

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): NCT02786056


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Mathieu GUILBART, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02786056    
Other Study ID Numbers: PI2014_843_0011
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Respiratory Function Tests
Lung