DermatomyositisNCT07037472
Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treatment Response Evaluation
A study testing Multi-modal photoacoustic/ultrasonic (PA/US) imaging system and Drug treatment in people with Dermatomyositis and Dermatomyositis With Calcinosis Cutis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dermatomyositis, Dermatomyositis With Calcinosis Cutis
- What is being tested?
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system and Drug treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients whose age at disease onset was <18 years and those with overlap syndrome and/or IBM were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Meng Yang, Doctor, 8601069155493, yangmeng_pumch@126.com
About this study
Official title: A Cohort Study Establishing a Standardized Scoring System in Dermatomyositis With Calcinosis Cutis and Assessing Treatment Response Via Multimodal Photoacoustic-Ultrasound Imaging
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.
Read the 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.
- Being tested
- Multi-modal photoacoustic/ultrasonic (PA/US) imaging system, Drug treatment
- Keywords
- Dermatomyositis, Dermatomyositis with Calcinosis cutis, Photoacoustic imaging
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemDiagnostic 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
Drug treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment at 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037472
- Sponsor's protocol ID
- PA/US Dermatomyositis
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Establishing a Standardized Scoring System in Dermatomyositis With Calcinosis Cutis and Assessing Treatment Response Via Multimodal Photoacoustic-Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT07037472
- Acronym / sponsor ID
- PA/US Dermatomyositis
- Keywords
- Dermatomyositis, Dermatomyositis with Calcinosis cutis, Photoacoustic imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM with calcinosis disease severity assessment based on PA/US imaging | Experimental | Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemEstablish 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. |
| DM patients with calcinosis planning to undergo drug treatment based on PA/US imaging | Experimental | Drug: Drug treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients whose age at disease onset was <18 years and those with overlap syndrome and/or IBM were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal photoacoustic/ultrasonic (PA/US) imaging systemThe 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 | Diagnostic test | DM with calcinosis disease severity assessment based on PA/US imaging |
| Drug treatmentThe 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. | Drug | DM patients with calcinosis planning to undergo drug treatment based on PA/US imaging |
Primary outcome
Identify photoacoustic features of skin lesions of DM with calcinosis and establish PA/US Scoring System for assessing disease severity of DM
Time frame: From enrollment to the end of treatment at 2 year
Photoacoustic excitation and photoacoustic imaging detection will be performed
Predict the treatment response of DM with calcinosis Using PA/US Parameters
Time frame: From enrollment to the end of treatment at 2 year
PA/US Scoring System will be used for assessing changes of DM disease severity after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal photoacoustic/ultrasonic (PA/US) imaging system and Drug treatment in people with Dermatomyositis and Dermatomyositis With Calcinosis Cutis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Yang, Doctor (8601060155493 ext. 8601060155493, yangmeng_pumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify photoacoustic features of skin lesions of DM with calcinosis and establish PA/US Scoring System for assessing disease severity of DM (time frame: From enrollment to the end of treatment at 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.