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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: DM with calcinosis disease severity assessment based on PA/US imagingExperimental treatment 1 intervention
Group B: DM patients with calcinosis planning to undergo drug treatment based on PA/US imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of treatment at 2 year
2

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

Time frame
From enrollment to the end of treatment at 2 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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