About this trial
Photoacoustic imaging (PAI) is an emerging biomedical modality that integrates the advantages of optical contrast and ultrasound imaging depth. Capable of providing morphological, functional, and molecular information, PAI shows significant promise for visualizing human superficial tissue. The goal of this clinical trial is to build a PAI evaluation method for DM skin lesions, explore its application value in assessing DM disease severity and evaluation of treatment response. The main questions it aims to answer are:
1. How to establish a non-invasive PA/US imaging evaluation method for DM skin lesions? 2. Can PAI precisely assess DM disease severity? 3. Can PAI systems predict the treatment response in DM with calcinosis cutis? Participants will receive regular PA/US imaging examinations during five stages of treatment (before treatment, 3 months, 6 months, 9 months and 12 months). And the effectiveness of PA/US in treatment response for DM at different time points will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients fulfilled the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myositis. Of the adult DM patients enrolled, those were found to have calcinosis and were subsequently included in our analysis.
Among enrollees with idiopathic inflammatory myositis, patients with pathognomonic skin rashes were subclassified as DM or amyopathic DM patients based on the 2017 EULAR/ACR classification tree.
For patients without pathognomonic skin manifestations, DM was defined according to muscle biopsy.
Patients with amyopathic DM were grouped with DM patients.
Disqualifiers
Patients whose age at disease onset was <18 years and those with overlap syndrome and/or IBM were excluded.
Trial design
Parallel
Treatments tested in this trial
Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
Diagnostic testThe multi-modal PA/US imaging system is equipped with a handheld PA/US probe, and able to provide data of dual-wavelength PA imaging of DM skin lesions, in addition to real-time 2D conventioanl US imaging
Drug treatment
DrugThe multi-modal PA/US imaging system is equipped with a handheld PA/US probe, and able to provide data of dual-wavelength PA imaging of DM skin lesions, in addition to real-time 2D conventional US imaging. The histopathological biopsy results before and after treatment are combined as indicators for evaluating therapeutic efficacy and predicting treatment outcomes.
Treatment groups
Trial outcomes
Primary outcomes
Identify photoacoustic features of skin lesions of DM with calcinosis and establish PA/US Scoring System for assessing disease severity of DM
Photoacoustic excitation and photoacoustic imaging detection will be performed
Predict the treatment response of DM with calcinosis Using PA/US Parameters
PA/US Scoring System will be used for assessing changes of DM disease severity after treatment
Sponsors and contacts
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