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临床试验/NCT03207997
NCT03207997已完成不适用

MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients by Using Elastic Registration Method: Feasibility Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Global and regional elasticity index compared to force vital capacity (FVC)

研究概览

简要总结

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.

详细描述

Scleroderma is a chronic connective tissue disease of poorly understood origin. The prevalence ranges between 100 and 260 cases per million inhabitants in Europe and the United States, with a female predominance (3/1). Pulmonary involvement is frequent, observed in 70 to 100% of the patients. It is the leading cause of death in scleroderma.

It has mainly two forms: diffuse fibrotic interstitial pneumonitis, which occurs in the majority of cases in the form of non-specific interstitial pneumonia (76%) and pulmonary arterial hypertension (PAH). PAH in scleroderma may be secondary to pulmonary fibrosis or develop on its own, in patients with no parenchymal involvement.

CT and pulmonary function tests play a very important role in the detection and follow-up of patients with lung disease associated with scleroderma. However, the analysis of HRCT, looking for ground glass opacities, reticulations, traction bronchiectasis, predominantly sub-pleural, basal and posterior remains semi-quantitative and shows great inter-observer variability, when based on visual assessment.

Diagnosis and staging of chronic lung diseases, such as scleroderma, is a major challenge for both patient care and approval of new treatments.

Magnetic resonance imaging (MRI) of lung disease may provide a non-invasive evaluation of lung fibrosis, bypassing radiation dose concerns of CT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Mild pulmonary fibrosis

Experimental

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

干预措施: unenhanced MR sequences (Other)

Moderate pulmonary fibrosis

Experimental

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

干预措施: unenhanced MR sequences (Other)

Severe pulmonary fibrosis

Experimental

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

干预措施: unenhanced MR sequences (Other)

Control group

Active Comparator

2 additional unenhanced MR sequences

干预措施: unenhanced MR sequences (Other)

结局指标

主要结局

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

时间窗: 1 day

Correlation to FVC

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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