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MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients (IRMSCLERO)

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ClinicalTrials.gov Identifier: NCT03207997
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Centrale Supelec School (Center for Visual Computing)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Assessment of pulmonary fibrosis is currently based on high-resolution CT (HRCT) and pulmonary function tests (PFT) such as forced vital capacity, (FVC) and carbon monoxide diffusion (DLCO). These techniques allow a semi-quantitative analysis of the pulmonary disease but are imperfect. The mains weaknesses are the lack of reproducibility, the limited sensitivity and for CT the resulting radiation dose.

Recent advances in MRI sequences allow exploring the lung parenchyma with millimeter slice thickness. Development of computer-assisted post-processing such as elastic registration opens new perspectives in the functional study of the lung parenchyma, especially the analysis of its deformation during the respiratory cycle and therefore of its elasticity.

Pulmonary involvement in scleroderma is present in 70 to 100% of patients and is the leading cause of death. Initial assessment of pulmonary involvement and follow-up are important for therapeutic decisions and patient prognosis. Quantitative analysis should be developed to reliably evaluate pulmonary fibrosis and increase the reproducibility.

The purpose of our study is to evaluate the feasibility of quantifying pulmonary fibrosis by successively performing full inspiration then full expiration volumetric MR acquisitions using a VIBE - Volumetric Interpolated Breath-hold examination sequence. Post processing of the 2 volumes using elastic registration is performed to evaluate pulmonary deformation in the normal and fibrotic lung areas, hypothesizing that it would be different.


Condition or disease Intervention/treatment Phase
Scleroderma Other: unenhanced MR sequences Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients by Using Elastic Registration Method: Feasibility Study
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Mild pulmonary fibrosis
mild pulmonary fibrosis (VFC> 75% theoretical and DLCO / VA> 55%) 2 additional unenhanced MR sequences
Other: unenhanced MR sequences
2 additional unenhanced MR sequences
Other Name: Imaging

Experimental: Moderate pulmonary fibrosis
moderate pulmonary fibrosis (VFC 50-75% and DLCO 36-55%) 2 additional unenhanced MR sequences
Other: unenhanced MR sequences
2 additional unenhanced MR sequences
Other Name: Imaging

Experimental: Severe pulmonary fibrosis
severe pulmonary fibrosis (VFC <50% theoretical or DLCO / VA <35%). 2 additional unenhanced MR sequences
Other: unenhanced MR sequences
2 additional unenhanced MR sequences
Other Name: Imaging

Active Comparator: Control group
2 additional unenhanced MR sequences
Other: unenhanced MR sequences
2 additional unenhanced MR sequences
Other Name: Imaging




Primary Outcome Measures :
  1. Global and regional elasticity index compared to force vital capacity (FVC) [ Time Frame: 1 day ]
    Correlation to FVC


Secondary Outcome Measures :
  1. Magnetic Resonance (MR) inspiratory volume compared to Total lung capacity (TLC) [ Time Frame: 1 day ]
  2. Magnetic Resonance (MR) expiratory volume compared to Residual Volume (RV) [ Time Frame: 1 day ]


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

Inclusion Criteria:

  • Patients aged 18 years or older
  • Having a diagnosis of diffuse or limited cutaneous systemic sclerosis (EULAR criteria 2013)
  • Referred for cardiac MRI
  • Having a thoracic assessment (CT and PFT) within 3 months
  • with social security insurance
  • Having given their consent

Exclusion Criteria:

  • MRI-related contraindications:

    • Pacemaker
    • Mechanical heart valve
    • Intracranial vascular clips before 1993
    • Foreign metallic ocular body
    • Cochlear Implant
    • Claustrophobic patients
    • Pregnant woman

      • Disease in exacerbation
      • Orthopnea
      • Inability to hold a 17-second apnea
      • Patients in the exclusion period following a previous search
      • Absence of thoracic evaluation by CT and PFT within 3 months

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): NCT03207997


Contacts
Contact: Marie-Pierre REVEL, MD, PhD +33 1 58 41 24 71 marie-pierre.revel@aphp.fr
Contact: Adèle BELLINO +33 1 58 41 11 95 adele.bellino@aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Marie-Pierre REVEL, MD, PhD    +33 1 58 41 24 71    marie-pierre.revel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Centrale Supelec School (Center for Visual Computing)
Investigators
Principal Investigator: Marie-Pierre REVEL, MD, PhD Assistance Publique - Hôpitaux de Paris

Additional Information:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03207997     History of Changes
Other Study ID Numbers: 2017-A00961-52
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 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 Assistance Publique - Hôpitaux de Paris:
Scleroderma
Pulmonary fibrosis
MRI
quantification

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases