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

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

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Other: Lung MRI examination

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	30 days
Comparison of signal-to-noise and contrast-to-noise ratio of lung parenchyma measured using UTE MRI to values published in the litterature.	30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Mathieu GUILBART, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (ESTIMATE): May 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Lung; Respiratory Function Tests
• Other Study ID Numbers: PI2014_843_0011