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

RecruitingNAAges 18 Years - 80 YearsAllPeking Union Medical College Hospital
NCT07037472 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
  • Drug treatment
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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