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

Recruiting now · Not applicable

Conditions studied: Dermatomyositis, Dermatomyositis With Calcinosis Cutis

In brief

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.

Key facts

Study ID

NCT07037472

Run by

Peking Union Medical College Hospital

People needed

100

Starts

2024-01-01

Expected to finish

2028-12-31

Last updated by the study team

2025-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Peking Union Medical College Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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