NCT07037472 Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treatment Response Evaluation
| NCT ID | NCT07037472 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Dermatomyositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07037472 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dermatomyositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07037472 currently recruiting?
Yes, NCT07037472 is actively recruiting participants. Contact the research team at yangmeng_pumch@126.com for enrollment information.
Where is the NCT07037472 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07037472 clinical trial?
NCT07037472 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 100 participants.