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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DM with calcinosis disease severity assessment based on PA/US imaging | Experimental | 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. |
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| DM patients with calcinosis planning to undergo drug treatment based on PA/US imaging | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-modal photoacoustic/ultrasonic (PA/US) imaging system | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From enrollment to the end of treatment at 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Yang, Doctor | Contact | 8601060155493 | 8601060155493 | yangmeng_pumch@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Drug treatment | Drug | 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. |
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| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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