An interventional study of Multi-modal photoacoustic/ultrasonic (PA/US) imaging system and Drug treatment in Dermatomyositis and Dermatomyositis With Calcinosis Cutis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic
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:
A multimodal photoacoustic-ultrasound (PA/US) system was integrated into a high-end commercial US platform, enabling real-time acquisition of grayscale imaging, color Doppler (CDUS), and dual-wavelength photoacoustic (PAI) data. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. Researchers plan to recruit participants of DM with calcinosis cutis from the department of rheumatology in Peking Union Medical College Hospital. The patients are scheduled to receive multi-modality PA/US imaging examinations, which integrated gray scale ultrasound (GSUS), ultra-micro-angiography (UMA) and PAI to realize visualization and assessment of subcutaneous soft tissues in morphology, hemodynamics, blood flow and oxygenation. This clinical trial aims to address three key objectives: the establishment of a non-invasive PA/US imaging evaluation method for DM skin lesions, the applicaiton to assess DM disease severity, and the use of PAI to monitor the treatment response.
171 studies on the registry are indexed under Dermatomyositis; 61 are open to participants now.
This study's planned enrollment of 100 is above the median of 31 across 125 interventional studies indexed under Dermatomyositis.
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Exclusion Criteria:
Establish a non-invasive photoacoustic-ultrasound (PA/US) imaging evaluation method for DM with calcinosis to identify the characteristic PA/US manifestations of DM patients with different types of skin lesions, and use PAI to further assess the disease severity of DM patient.
Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
Patients over 18 years of age with histopathologically or clinically confirmed diagnoses based on the 2017 EULAR/ACR classification criteria who plan to undergo drug treatment.
Drug: 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 conventioanl US imaging
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.
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
Time frame: From enrollment to the end of treatment at 2 year
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
Time frame: From enrollment to the end of treatment at 2 year
Plan to share: Undecided
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