Muscle Imaging Project Using ANatomopathology and Full Field Optical Coherence Tomography

NCT07552220 | Not Yet Recruiting

• 1 other identifier: PIMANT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myositis; Health Adult Subjects

Keywords

anatomopathology; Full field optical coherence tomography; muscle biopsies; Myositis and healthy patients

Outcome Measures

Primary Outcomes (2)

• Evaluation of the spatial resolution of the two methods

  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.

  2 years

• Evaluation of inflammation detection of the two methods

  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.

  2 years

Secondary Outcomes (1)

• Establish the advantages and limitations of the two methods

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Myositis or healthy major patients

You may qualify if:

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

You may not qualify if:

• Patient \< 18 years old

Sponsors & Collaborators

• Centre Hospitalier de Mâcon: lead

Study Sites (1)

Centre Hospitalier de Mâcon

Mâcon, 71000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Frozen muscle biopsies

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Thibault Maillet, Doctor

CONTACT

+333 85 27 73 43; thmaillet@ch-macon.fr

Emilie Chopin, Biology master

CONTACT

+333 85 27 56 86; emchopin@ch-macon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)