Photoacoustic and ultrasound imaging for dermatomyositis with calcinosis cutis
Official title: A Cohort Study Establishing a Standardized Scoring System in Dermatomyositis With Calcinosis Cutis and Assessing Treatment Response Via Multimodal Photoacoustic-Ultrasound Imaging
Run by Peking Union Medical College Hospital · NCT07037472 · Data updated 2026-11-12
This project will try a combined photoacoustic and ultrasound scan to see if it can monitor skin disease activity and treatment response in adults with dermatomyositis who have calcinosis cutis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT07037472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with dermatomyositis (including amyopathic DM) who meet the 2017 EULAR/ACR criteria and have clinically evident calcinosis cutis are ideal candidates.
✕Probably not a fit
Patients with disease onset before age 18, those with overlap syndromes or inclusion body myositis, and people without calcinosis are not eligible and are unlikely to benefit from this enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use a multimodal photoacoustic/ultrasound (PA/US) system integrated into a commercial ultrasound platform to collect grayscale, color Doppler/ultra-micro-angiography, and dual-wavelength photoacoustic data from affected skin. Imaging will be performed with a hand-held probe at five time points: baseline, 3, 6, 9, and 12 months while patients receive standard drug treatment. The protocol aims to quantify morphology, blood flow, hemodynamics, and oxygenation in subcutaneous tissues to develop a non-invasive evaluation method for DM skin lesions. Collected imaging metrics will be compared to clinical measures to determine whether PA/US can track disease severity and predict treatment response.
Why it matters
Potential benefit: If successful, this method could give clinicians a non-invasive imaging biomarker to track disease activity and guide treatment decisions for dermatomyositis patients with calcinosis cutis.
How similar studies have gone: Photoacoustic imaging has shown promise in pilot work for skin and vascular imaging, but applying PA/US specifically to dermatomyositis with calcinosis cutis is largely novel and not yet validated.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Meng Yang, Doctor
- Email: yangmeng_pumch@126.com
- Phone: 8601060155493
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.