Muscle Imaging Project Using ANatomopathology and Full Field Optical Coherence Tomography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier de Mâcon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient > 18 years old ans has given his oral consent
Patient who biospies are performed as part of care
Disqualifiers
Patient < 18 years old
Trial population
Myositis or healthy major patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Healthy patients
Group B: Myositis patients
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 yearsSecondary outcomes
1
Establish the advantages and limitations of the two methods
Define the averages for sample preparation time, acquisition time and result delivery time for each method. Compare the quality of the results obtained by the two techniques according to the two previous evaluation criteria (visual assessment by pathologists, accuracy, recall and AI F1 score)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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