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

NCT ID: NCT07037472

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2028-12-31

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. 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.

Detailed Description

A multimodal photoacoustic-ultrasound (PA/US) system was integrated into a high-end commercial US platform, enabling real-time acquisition of grayscale imaging, color Doppler (CDUS), and dual-wavelength photoacoustic (PAI) data. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. Researchers plan to recruit participants of DM with calcinosis cutis from the department of rheumatology in Peking Union Medical College Hospital. The patients are scheduled to receive multi-modality PA/US imaging examinations, which integrated gray scale ultrasound (GSUS), ultra-micro-angiography (UMA) and PAI to realize visualization and assessment of subcutaneous soft tissues in morphology, hemodynamics, blood flow and oxygenation. This clinical trial aims to address three key objectives: the establishment of a non-invasive PA/US imaging evaluation method for DM skin lesions, the applicaiton to assess DM disease severity, and the use of PAI to monitor the treatment response.

Conditions

Dermatomyositis; Dermatomyositis With Calcinosis Cutis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 patients with calcinosis planning to undergo drug treatment based on PA/US imaging

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.

Group Type: EXPERIMENTAL

Drug treatment

Intervention Type: 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.

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Drug treatment

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Yang, Doctor

Role: CONTACT

yangmeng_pumch@126.com

8601060155493 ext. 8601060155493

Facility Contacts

Meng Yang, Doctor

Role: primary

yangmeng_pumch@126.com

8601069155493

Other Identifiers

PA/US Dermatomyositis

Identifier Type: -

Identifier Source: org_study_id