ClinicalTrials.gov record NCT07037472

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 80 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional diagnostic study uses a combined photoacoustic and ultrasound (PA/US) scanner to image skin lesions in people with dermatomyositis, especially those with calcinosis cutis. Participants receive PA/US imaging before treatment and at 3, 6, 9, and 12 months. The study aims to build a scoring system from these images and test whether imaging features relate to treatment response.

What it is studying. Whether multimodal photoacoustic‑ultrasound (PA/US) imaging can identify characteristic features of dermatomyositis skin lesions, support a standardized PA/US scoring system for disease severity, and be used to assess or predict treatment response in patients with calcinosis cutis.

What the researchers hope to learn. Develop a non‑invasive PA/US imaging method for dermatomyositis skin lesions; establish a PA/US scoring system to assess disease severity; evaluate whether PA/US parameters relate to or predict treatment response in dermatomyositis with calcinosis cutis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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:

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Drug treatment
Diagnostic test
  • Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have repeated multi‑modality photoacoustic/ultrasound (PA/US) imaging using a handheld probe (including gray‑scale ultrasound, ultra‑micro‑angiography, and dual‑wavelength photoacoustic imaging). Imaging is planned at five time points: before treatment and at 3, 6, 9, and 12 months. Some participants may have histopathology (biopsy) results used before and after treatment as part of evaluation. Some participants are in a drug-treatment arm: people planning to receive drug treatment have PA/US imaging (and sometimes biopsy) before and after treatment to evaluate response. Participants may be followed for outcomes through about 2 years.

How the study is structured. A randomized, parallel‑group, single‑masked interventional diagnostic study. Participants undergo multimodal PA/US imaging (grayscale ultrasound, micro‑angiography and dual‑wavelength photoacoustics) at baseline and at scheduled follow‑up visits (including 3, 6, 9, and 12 months) to compare imaging findings over time and between study groups.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Study completion
Dec 31, 2028 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Jun 25, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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