Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treatment Response Evaluation

Condition(s) studied

Investigational drug(s) / intervention(s)

Multi-modal photoacoustic/ultrasonic (PA/US) imaging system: The 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: The 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.

Study summary

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

Primary outcome measure(s)

• Identify photoacoustic features of skin lesions of DM with calcinosis and establish PA/US Scoring System for assessing disease severity of DM — From enrollment to the end of treatment at 2 year
  Photoacoustic excitation and photoacoustic imaging detection will be performed
• Predict the treatment response of DM with calcinosis Using PA/US Parameters — From enrollment to the end of treatment at 2 year
  PA/US Scoring System will be used for assessing changes of DM disease severity after treatment

Trial sites (1)

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