MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients

NCT03207997 | Completed

• 2 other identifiers: K170304J2017-A00961-52
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Keywords

Scleroderma; Pulmonary fibrosis; MRI; quantification

Outcome Measures

Primary Outcomes (1)

• Global and regional elasticity index compared to force vital capacity (FVC)

  Correlation to FVC

  1 day

Secondary Outcomes (2)

• Magnetic Resonance (MR) inspiratory volume compared to Total lung capacity (TLC)

  1 day

• Magnetic Resonance (MR) expiratory volume compared to Residual Volume (RV)

  1 day

Study Arms (4)

Mild pulmonary fibrosis

EXPERIMENTAL

mild pulmonary fibrosis (VFC\> 75% theoretical and DLCO / VA\> 55%) 2 additional unenhanced MR sequences

Other: unenhanced MR sequences

Moderate pulmonary fibrosis

EXPERIMENTAL

moderate pulmonary fibrosis (VFC 50-75% and DLCO 36-55%) 2 additional unenhanced MR sequences

Other: unenhanced MR sequences

Severe pulmonary fibrosis

EXPERIMENTAL

severe pulmonary fibrosis (VFC \<50% theoretical or DLCO / VA \<35%). 2 additional unenhanced MR sequences

Other: unenhanced MR sequences

Control group

ACTIVE COMPARATOR

2 additional unenhanced MR sequences

Other: unenhanced MR sequences

Interventions

unenhanced MR sequences OTHER

2 additional unenhanced MR sequences

Also known as: Imaging

Control group; Mild pulmonary fibrosis; Moderate pulmonary fibrosis; Severe pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Absence of thoracic evaluation by CT and PFT within 3 months

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• The Center of Visual Computing, CentraleSupélec, Paris-Saclay University: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

Location

Related Publications (1)

• Chassagnon G, Martin C, Marini R, Vakalopolou M, Regent A, Mouthon L, Paragios N, Revel MP. Use of Elastic Registration in Pulmonary MRI for the Assessment of Pulmonary Fibrosis in Patients with Systemic Sclerosis. Radiology. 2019 May;291(2):487-492. doi: 10.1148/radiol.2019182099. Epub 2019 Mar 5.

  PMID: 30835186 RESULT

Related Links

• This is the French website about the occurent disease, linked with patient association and all the research about this subject in France

MeSH Terms

Conditions

Scleroderma, Diffuse; Pulmonary Fibrosis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Marie-Pierre REVEL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: September 18, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)