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

NCT07037472 | Recruiting

• 1 other identifier: PA/US Dermatomyositis
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.How to establish a non-invasive PA/US imaging evaluation method for DM skin lesions?
2. 2.Can PAI precisely assess DM disease severity?
3. 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.

Conditions

Dermatomyositis; Dermatomyositis With Calcinosis Cutis

Keywords

Dermatomyositis; Dermatomyositis with Calcinosis cutis; Photoacoustic imaging

Outcome Measures

Primary Outcomes (2)

• 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

  From enrollment to the end of treatment at 2 year

• 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

  From enrollment to the end of treatment at 2 year

Study Arms (2)

DM with calcinosis disease severity assessment based on PA/US imaging

EXPERIMENTAL

Establish a non-invasive photoacoustic-ultrasound (PA/US) imaging evaluation method for DM with calcinosis to identify the characteristic PA/US manifestations of DM patients with different types of skin lesions, and use PAI to further assess the disease severity of DM patient.

Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

DM patients with calcinosis planning to undergo drug treatment based on PA/US imaging

EXPERIMENTAL

Patients over 18 years of age with histopathologically or clinically confirmed diagnoses based on the 2017 EULAR/ACR classification criteria who plan to undergo drug treatment.

Drug: Drug treatment

Interventions

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

DM with calcinosis disease severity assessment based on PA/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.

DM patients with calcinosis planning to undergo drug treatment based on PA/US imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Dermatomyositis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Meng Yang, Doctor

CONTACT

8601060155493; yangmeng_pumch@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 25, 2025

Record last verified: 2024-06

Locations

CN (1)