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

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  • Are you between 18 and 80 years old?

Source: NCT07037472, who can take part

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Trial details

Who runs it
Peking Union Medical College Hospital
Trial code
NCT07037472
Record updated
25 June 2025
Original description
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:Read full original descriptionShow less

A Cohort Study Establishing a Standardized Scoring System in Dermatomyositis With Calcinosis Cutis and Assessing Treatment Response Via Multimodal Photoacoustic-Ultrasound Imaging

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.

Inclusion: 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: Patients whose age at disease onset was <18 years and those with overlap syndrome and/or IBM were excluded.

ClinicalTrials.gov NCT07037472