Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)

Обзор

Spirometry is now the gold standard technique for assessing lung function in humans. From the shape of a flow-volume curve measured while the patient, trained by the practitioner, performs forced breaths, the forced vital capacity (FVC) and the forced expiratory volume in one second (FEV1) can be deduced and the pulmonologist is able to detect and characterize respiratory diseases as well as to evaluate current treatments. This technique is non-invasive and simple. It is widely available, robust, reproducible and sensitive to intervention. However, it requires proactive cooperation from the patient and only measures global pulmonary ventilation, without locoregional information. An innovative strategy and an original study framework have been developed in the BioMaps laboratory to establish local maps of flow-volume curves across the lung and to jointly analyze ventilatory function and mechanical behavior at any point in the lung: 3D magnetic resonance spirometry. As respiratory mechanics fundamentally supports ventilatory function, this technique should open a new avenue to non-invasively explore lung function while providing a better diagnosis of regional lung diseases.

Подробное описание

Main objectiif / Evaluate the concordance of the results provided by 3D spirometry using compared with those obtained by spirometry in four populations: healthy four populations: healthy volunteers, asthma patients, patients with chronic obstructive pulmonary, chronic obstructive pulmonary disease (COPD) and lung transplant patients. with and without bronchiolitis obliterans syndrome (BOS). obliterative bronchiolitis syndrome (BOS).

Вмешательства

• Диагностический тест 1. Standard spirometry
  Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
• Диагностический тест 2. 3D dynamic lung MRI at UTE in prone and supine positions
  Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
• Препарат 3. Reversibility test with salbutamol
  Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).
• Диагностический тест 4. 3D dynamic lung MRI at UTE in supine and prone position
  Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.

Первичные конечные точки

• Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC [Срок оценки: 2 months]
• Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs [Срок оценки: 2 months]
• Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions [Срок оценки: 2 months]

Критерии участия

Критерии включения

Generic inclusion criteria

• Ability to understand the nature and objectives of the study
• Ability to remain immobile in an MRI scanner in supine position for the entire duration of the acquisitions
• Ability to give free and informed written consent Specific inclusion criteria for healthy volunteers
• Age: 18-45 years
• No known and diagnosed pulmonary pathology such as respiratory insufficiency, COPD, asthma or cancer
• Ability to remain motionless in an MRI scanner in a prone position for a total of 50 min.
• Non-smoker and non-smoker Specific inclusion criteria for asthma patients
• Age: 18-80 years
• Asthma of varying degrees of severity, depending on inhalation required to achieve control:
• Diagnosis of asthma classified as moderate according to the Global initiative for asthma (GINA) guidelines for at least 6 months
• Diagnosis of asthma classified as severe according to the Global initiative for asthma (GINA) guidelines for at least 6 months months with initiation of biotherapy planned by their pulmonologist
• Non-smoker and non-vapourist Specific inclusion criteria for COPD patients
• Age: 40-80 years
• COPD of varying degrees of severity:
• Diagnosis of COPD classified as moderate according to the Global initiative for chronic obstructive lung disease guidelines (GOLD 2: VEMS = 50-79%)
• Diagnosis of COPD classified as severe according to the guidelines for chronic obstructive lung disease (GOLD 3: VEMS = 30-49%) Specific inclusion criteria for patients with bilateral lung transplants with BOS
• Age: 18-90 years
• Irreversible FEV1 < 80% of baseline with FEV1/FVC ratio FEV1/FVC < 0.7
• Absence of visible parenchymal opacity on CT scan (non inclusion of mixed RAS/CLAD)
• Absence of significant bronchial stenosis (having required endoscopic endoscopic treatment)
• No diaphragmatic involvement (established by sniff test under fluoroscopy fluoroscopy or diaphragmatic ultrasound) Specific inclusion criteria for patients with bilateral lung transplants without BOS
• Age: 18-90 years
• FEV1 > 90% baseline for more than 24 months after the date of date of lung transplantation
• Absence of significant bronchial stenosis (requiring endoscopic endoscopic treatment)
• Absence of diaphragmatic impairment (established by sniff test under fluoroscopy or diaphragmatic ultrasound)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CEA | Service Hospitalier Fréderic Joliot — Orsay

Идентификаторы

NCT: NCT05724745 · CEA 100-061 · 2021-A00672-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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