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Clinical Trials in China / NCT07037472
Recruiting Not applicable

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

NCT07037472 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Not applicable
Started
2024-01-01
Last updated
2025-06-25

Condition(s) studied

DermatomyositisDermatomyositis With Calcinosis Cutis

Investigational drug(s) / intervention(s)

Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemDrug treatment

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * Calcinosis diagnosis was based on clinical examination findings. Exclusion Criteria: * Patients whose age at disease onset was \<18 years and those with overlap syndrome and/or IBM were excluded.

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)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China Recruiting

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Other trials for the same condition

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Enrolling by invitation
3T Therapy in the Treatment of MDA5-positive Dermatomyositis Enrolling by invitation
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM) Recruiting
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies Recruiting
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037472 on ClinicalTrials.gov ↗ ← All trials in China