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Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases (PIMABOD)

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ClinicalTrials.gov Identifier: NCT04341701
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.

Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.


Condition or disease Intervention/treatment Phase
Asthma Copd Procedure: MRI Not Applicable

Detailed Description:

Bronchial obstructive diseases such as asthma and chronic obstructive pulmonary disease (COPD) are very common and represent a major public health problem. The distinction between these two diseases is sometimes difficult. In each of these diseases, several clinical phenotypes or biological endotypes have been defined. For example, frequent exacerbating patients and / or hypereosinophilic patients are present in both diseases. In the severe states, cardiovascular comorbidities are the most frequent comorbidities and alter the prognosis.

In these chronic obstructive patients, computed tomography (CT) allows a multimodal analysis of the bronchial wall, the lung parenchyma and pulmonary vessels. CT also allows a score analysis of coronary plaques. However, irradiation is significant and increases with repeated examinations. CT does not allow a comprehensive analysis of cardiac function, or an estimate of pulmonary artery pressure.

Magnetic Resonance Imaging (MRI) is a proton non-ionizing alternative to CT, in particular when using 3D ultra-short echo-time (UTE) sequences. These 3D-UTE sequences decrease the effects of magnetic susceptibility and provide morphological and morphometric information on bronchi and lung comparable to those obtained by CT. Moreover, dedicated sequences add functional information on bronchi. Heart MRI allows more analyses, such as right and left ventricular systolic functions, an indirect estimate of pulmonary arterial pressure and the amount of diffuse myocardial fibrosis.

Our project aims to identify morphological phenotypes through the pulmonary and heart MRI in patients with obstructive lung disease

.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: diagnostic imaging pilot study, exploratory, prospective, multi-center
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
Estimated Study Start Date : June 5, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
COPD
COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist
Procedure: MRI
The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent

Asthma
asthma according to GINA 2019 but without any smoking restriction
Procedure: MRI
The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent




Primary Outcome Measures :
  1. Determine the number of the clusters [ Time Frame: Day 30 ]
    Number of the clusters will be defined using principal component analysis and dendrogram, based on the multimodal lung and heart MRI analysis

  2. Determine the Quality of the clusters [ Time Frame: Day 30 ]
    Quality of the clusters will be defined using Dunn index and non-hierarchical analysis based on the multimodal lung and heart MRI analysis


Secondary Outcome Measures :
  1. Assessment of age [ Time Frame: Day 1 ]
  2. Assessment of sexe [ Time Frame: Day 1 ]
  3. Assessment of tobacco consumption [ Time Frame: Day 1 ]
  4. Assessment of disease duration [ Time Frame: Day 1 ]
  5. Evaluation score of SF-36 questionnaire [ Time Frame: Day 1 ]
    Determine the quality of life. SF36: 36-Item Short Form health survey Minimum = 0 and maximum = 100 Higher score means better outcome

  6. Evaluation with St Georges Quality of Life Questionnaire [ Time Frame: Day 30 ]
    Determine the quality of life. Minimum = 0 and maximum = 100 Higher score means worse outcome

  7. Evaluation of comorbidities [ Time Frame: Day 1 ]

    The presence of various comorbidities will be checked in a yes/No manner :

    • rhinitis
    • sinusitis
    • nasal polyposis
    • gastroesophageal reflux
    • obstructive sleep apnea
    • depression
    • anxiety
    • allery
    • heart failure (Left or Right)
    • hypertension
    • myocardial infarction
    • stroke
    • arteriopathy
    • arythmia
    • diabetis
    • dyslipidaemia
    • obesity
    • denutrition
    • osteoporosis

  8. Determine of Forced Expiratory Volume in one sec (FEV-1) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
    Assessment of FEV-1/FVC during spirometry before and after bronchodilator

  9. Determine of Forced Vital Capacity (FVC) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
    Assessment of FEV-1/FVC during spirometry before and after bronchodilator

  10. Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
  11. Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
  12. Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
  13. Determine of Residual Volume (RV) during spirometry before and after bronchodilator [ Time Frame: day 1 ]
  14. Determine of Carbon monoxide transfer capacity (TLCO) [ Time Frame: day 1 ]
  15. Determine the value of blood heamoglobin [ Time Frame: day 1 ]
  16. Determine the value of blood eosinophils [ Time Frame: day 1 ]
  17. Determine the value of blood C-reactive protein [ Time Frame: day 1 ]
  18. Determine the value of blood B-type natriuretic peptide [ Time Frame: day 1 ]
  19. Determine the value of blood total IgE at [ Time Frame: day 1 ]
  20. Determine the value of blood total IgE [ Time Frame: day 1 ]


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.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman aged between 40 and 70 years.
  • Having benefited under the current care of spirometry showing FEV / FVC pre-bronchodilation <0.70 at steady state (i.e., without exacerbation from at least 4 weeks).
  • Having a diagnosis of asthma according to GINA 2019 without smoking restrictions or COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility to bronchodilator established by the pulmonologist.
  • On stable cardiopulmonary medications for at least 4 weeks
  • Having given his written informed consent.

Exclusion Criteria:

  • Subject deprived of liberty by judicial or administrative decision.
  • Major protected by law.
  • Subject not affiliated to a social security scheme, whether or not the beneficiary of such a regime.
  • Pregnant or breastfeeding women
  • Inability to complete the Questionnaire SF-36 and SGQLQ.
  • Subject in times of exclusion in relation to another protocol.
  • History of pulmonary fibrosis, primary pulmonary hypertension and cystic fibrosis.
  • History of lung resection (referred to oncological or volume reduction)
  • History of cancer except skin cancer (squamous and Basal) under 5 years
  • History of chest radiation
  • Pacemaker carrier subject or implantable defibrillator, intraocular metallic foreign body, metal clip intracranial, heart valve prosthesis kind Starr-Edwards pre-6000, or biomedical insulin pump type device, Neurostimulator or cochlear implant, Metal patches.
  • Subject claustrophobic or unable to stay elongate during 30 minutes.
  • Subject with a waist circumference greater than 200 cm.
  • Occurrence of an exacerbation between the FE and MRI
  • Uninterpretable MRI

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): NCT04341701


Contacts
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Contact: Patrick BERGER, MD, PhD +335 57 65 65 13 patrick.berger@chu-bordeaux.fr
Contact: Virginie NIEL +335 57 62 31 94 virginie.niel@chu-bordeaux.fr

Locations
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France
Centre hospitalier de la Côte Basque
Bayonne, France, 64100
Contact: Elise ABRAHAM, MD    +335 59 44 35 35    eabraham@ch-cotebasque.fr   
Principal Investigator: Elise ABRAHAM, MD         
Clinique Saint Augustin
Bordeaux, France, 33000
Contact: Annaig OZIER, MD    +335 56 24 21 79    ozierannaig@icloud.com   
Principal Investigator: Annaig OZIER, MD         
Centre Médical Toki Eder
Cambo-les-Bains, France, 64250
Contact: Alain BERNADY, MD    +335 59 93 56 00    al.bernady@gmail.com   
Principal Investigator: Alain BERNADY, MD         
Hôpital Le Cluzeau - CHU de Limoges
Limoges, France, 87000
Contact: Boris MELONI, MD    +335 55 05 68 81    boris.melloni@chu-limoges.fr   
Principal Investigator: Boris MELONI, MD         
Centre de Pneumologie Bordeaux Rive droite
Lormont, France, 33310
Contact: Laurent FALQUE, MD    +335 56 32 80 58    laurent.falque@orange.fr   
Principal Investigator: Laurent FALQUE, MD         
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, France, 33600
Contact: Patrick BERGER, MD, PhD    +335 57 65 65 13    patrick.berger@chu-bordeaux.fr   
Contact: Virginie NIEL    +335 57 62 31 94    virginie.niel@chu-bordeaux.fr   
Sub-Investigator: Pierre-Olivier GIRODET, MD, PhD         
Principal Investigator: Patrick BERGER, MD, PhD         
Sub-Investigator: Maéva ZYSMAN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Patrick BERGER, MD, PhD University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04341701    
Other Study ID Numbers: CHUBX 2018/37
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
MRI
multimodal
phenotypes
lung
heart