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临床试验/NCT07552220
NCT07552220尚未招募不适用

Muscle Imaging Project Using ANatomopathology and Full Field Optical Coherence Tomography

Centre Hospitalier de Mâcon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Evaluation of the spatial resolution of the two methods

研究概览

简要总结

Myositis is an inflammatory disease of the skeletal muscles that can be caused by infections, autoimmune diseases, or medications. Early diagnosis of these conditions is essential for optimal treatment. Anatomic pathology is the conventional method used to analyze muscle lesions, but it requires several weeks to obtain results. Full-field optical coherence tomography (OCT), a non-invasive imaging technique, could offer advantages in terms of speed and resolution for visualizing muscle inflammation.

This research project compares histological pathology and full-field OCT for the analysis of muscle biopsies from healthy individuals and patients suspected of having myositis. The aim of this study is to establish an OCT reference standard by analyzing control muscle biopsies and then comparing muscle inflammation in confirmed cases of myositis. The advantages and limitations of both methods will also be evaluated.

详细描述

Introduction Myositis represents a group of inflammatory diseases affecting skeletal muscles, characterized by inflammatory infiltration of muscle tissue. This condition can have various etiologies, such as infections, autoimmune diseases (like dermatomyositis or polymyositis), or drug-induced diseases. Early diagnosis and accurate assessment of muscle inflammation are essential for the therapeutic management of these patients.

Conventional analytical techniques, such as histopathology, allow visualization and analysis of muscle lesions and inflammation using stains on histological sections. However, this method requires several weeks of work before a result can be obtained. Full-field optical coherence tomography (OCT), a non-invasive imaging technique, could offer significant advantages in terms of speed of examination and resolution of muscle structures, particularly for visualizing inflammatory infiltration.

This research project proposes to compare conventional histopathology and full-field optical coherence tomography for the analysis of muscle biopsies from both healthy individuals and patients with suspected myositis.

The main objective of this prospective and comparative study will be to first establish a reference standard by analyzing control biopsies using both methods, and then to similarly evaluate the muscle inflammation detected in confirmed cases of myositis. The respective advantages and limitations of each technique will be assessed in the detection of this pathology.

Research Objectives

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient > 18 years old ans has given his oral consent
  • Patient who biospies are performed as part of care

排除标准

  • Patient < 18 years old

研究组 & 干预措施

Healthy patients

Muscle biopsies collected during orthopedic surgery (performed as part of care)

Myositis patients

Muscle biopsies collected as part of care to establish a diagnosis

结局指标

主要结局

Evaluation of the spatial resolution of the two methods

时间窗: 2 years

Image acquisitions will be performed on the same samples (fresh tissue for OCT and frozen tissue for histology) with an identical section thickness. To obtain structural tissue data, OCT acquisitions will be performed in full field mode (FF-OCT), and Hematoxylin-Eosin, Gomori's trichrome and NADH staining will be carried out on histological sections. For each method, the criteria evaluated will be the ability to detect fiber structure, the presence of fibrosis and blood vessels. Image comparison will be performed by specialized pathologists and then by an autoML type artificial intelligence, with assessment of accuracy and recall.

Evaluation of inflammation detection of the two methods

时间窗: 2 years

Image acquisition will be performed on the same samples (fresh tissue for OCT and frozen tissue for histology) with an identical section thickness. OCT acquisitions will be carried out in dynamic colorimetric mode (DCI) to observe the intensity and variability of metabolic activity across the entire fresh tissue sample using a color panel ranging from blue to red. Inflammation detection on histological sections will be observed using the markers HLA1, HLA-DR, C5B9, P62, CD31, CD56. The potential correlation between metabolic activity and inflammation will be visually assessed by specialized pathologists and by an autoML type artificial intelligence with assessment of accuracy and recall.

次要结局

  • Establish the advantages and limitations of the two methods(2 years)

研究者

发起方
Centre Hospitalier de Mâcon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thibault MAILLET

Doctor

Centre Hospitalier de Mâcon

研究点 (1)

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