Dermatomyositis (DM)NCT07531446
Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters
An observational study of Dermatomyositis (DM) and ILD, run by Ruijin Hospital at 1 site in China.
Trial summary
The investigators investigated the associations between the imaging parameters of ⁶⁸Ga-FAPI and ¹⁸F-FDG dual-tracer PET/CT and concomitant interstitial lung disease (ILD) in patients with dermatomyositis (DM), developed a novel diagnostic model to predict DM complicated with ILD, and conducted external validation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis (DM), ILD, Machine Learning
- What is being tested?
- Observe the medical images and Extracting image feature
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 1 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between June 2023 and July 2025, 154 consecutive patients diagnosed with dermatomyositis (DM) who underwent 68Ga-FAPI-04 PET/CT imaging were initially considered. The diagnosis of DM was established based on Bohan and Peter criteria for classic DM [24], or Sontheimer criteria for clinically amyopathic dermatomyositis (CADM)[25]. The diagnosis of interstitial lung disease (ILD) was confirmed by a multidisciplinary team based on a combination of clinical symptoms (cough, dyspnea), physical findings (inspiratory crackles), high-resolution computed tomography (HRCT) evidence of interstitial changes, and pulmonary function tests showing restrictive ventilator defects.
Who may be able to join
- The diagnosis of dermatomyositis (DM) was made in accordance with the Bohan and Peter criteria
- The diagnosis of clinically amyopathic dermatomyositis (CADM) was established based on the Sontheimer criteria
- The diagnosis of interstitial lung disease (ILD) was confirmed in line with the criteria of the American Thoracic Society (ATS)
- ⁶⁸Ga-FAPI and ¹⁸F-FDG PET/CT scans were performed in the Department of Nuclear Medicine.
- Exclusion Criteria: Patients with other connective tissue diseases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine & Institute for medical imaging technology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality
About this study
The investigators investigated the associations between the imaging parameters of ⁶⁸Ga-FAPI and ¹⁸F-FDG dual-tracer PET/CT and concomitant interstitial lung disease (ILD) in patients with dermatomyositis (DM), developed a novel diagnostic model to predict DM complicated with ILD, and conducted external validation of this model. Meanwhile, the investigators compared the predictive performance of the imaging-only model with that of the classic clinical model and the clinical-radiological collaborative model.
Read the detailed description
For the features included in the final optimal model, between-group comparisons of continuous variables (interstitial lung disease group vs. non-interstitial lung disease group) were performed using the Wilcoxon rank-sum test. For categorical variables, the Chi-square test or Fisher's exact test was adopted as appropriate.In the comparison of model efficacy, the DeLong test was used to assess the statistical differences in AUC values between each machine learning classifier and the reference model.All statistical analyses were conducted using R software (version 4.4.1). The corresponding R packages applied included pROC for ROC analysis, caret for model training, and SHAP for the interpretability analysis of the XGBoost model. A two-tailed p-value < 0.05 was defined as the threshold of statistical significance for all analyses.
- Conditions
- Dermatomyositis (DM), ILD, Machine Learning, Radiomics
- Being tested
- Observe the medical images, Extracting image feature
- Keywords
- positron emission tomography/computed tomography, dermatomyositis, ILD, machine learning, radiomics
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe the medical imagesOther
Observe the medical images via work station or local image analysing software
Extracting image featureOther
Extracting image feature via radiomics or machine learning methods
| Study group | Role | What they receive |
|---|---|---|
| ILD | The diagnosis of ILD was confirmed in line with the criteria of the American Thoracic Society (ATS). Receives: Other: Observe the medical images; Other: Extracting image feature | |
| non-ILD | Patients in the non-ILD group had no evidence of ILD as judged by ATS criteria. Receives: Other: Observe the medical images; Other: Extracting image feature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging features of 68Ga-FAPI PET image
conventional PET parameters (SUVmax, SUVmin) and PET textural feature parameters (radiomics)
Measured: baseline
Secondary outcomes (1)
Performance of Machine Learning and Reference Models
ROC curve (Receiver Operating Characteristic curve)、DCA curve (Decision Curve Analysis curve)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start13 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatomyositis (DM)Studies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531446
- Sponsor's protocol ID
- RuijinH 2026-47
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters
- ClinicalTrials.gov ID
- NCT07531446
- Acronym / sponsor ID
- RuijinH 2026-47
- Conditions
- Dermatomyositis (DM), ILD, Machine Learning, Radiomics
- Keywords
- positron emission tomography/computed tomography, dermatomyositis, ILD, machine learning, radiomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
The investigators investigated the associations between the imaging parameters of ⁶⁸Ga-FAPI and ¹⁸F-FDG dual-tracer PET/CT and concomitant interstitial lung disease (ILD) in patients with dermatomyositis (DM), developed a novel diagnostic model to predict DM complicated with ILD, and conducted external validation of this model. Meanwhile, the investigators compared the predictive performance of the imaging-only model with that of the classic clinical model and the clinical-radiological collaborative model.
Detailed description
For the features included in the final optimal model, between-group comparisons of continuous variables (interstitial lung disease group vs. non-interstitial lung disease group) were performed using the Wilcoxon rank-sum test. For categorical variables, the Chi-square test or Fisher's exact test was adopted as appropriate.In the comparison of model efficacy, the DeLong test was used to assess the statistical differences in AUC values between each machine learning classifier and the reference model.All statistical analyses were conducted using R software (version 4.4.1). The corresponding R packages applied included pROC for ROC analysis, caret for model training, and SHAP for the interpretability analysis of the XGBoost model. A two-tailed p-value < 0.05 was defined as the threshold of statistical significance for all analyses.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILD | – | Other: Observe the medical images, Other: Extracting image featureThe diagnosis of ILD was confirmed in line with the criteria of the American Thoracic Society (ATS). |
| non-ILD | – | Other: Observe the medical images, Other: Extracting image featurePatients in the non-ILD group had no evidence of ILD as judged by ATS criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between June 2023 and July 2025, 154 consecutive patients diagnosed with dermatomyositis (DM) who underwent 68Ga-FAPI-04 PET/CT imaging were initially considered. The diagnosis of DM was established based on Bohan and Peter criteria for classic DM [24], or Sontheimer criteria for clinically amyopathic dermatomyositis (CADM)[25]. The diagnosis of interstitial lung disease (ILD) was confirmed by a multidisciplinary team based on a combination of clinical symptoms (cough, dyspnea), physical findings (inspiratory crackles), high-resolution computed tomography (HRCT) evidence of interstitial changes, and pulmonary function tests showing restrictive ventilator defects.
Key inclusion criteria (5 listed)
- The diagnosis of dermatomyositis (DM) was made in accordance with the Bohan and Peter criteria
- The diagnosis of clinically amyopathic dermatomyositis (CADM) was established based on the Sontheimer criteria
- The diagnosis of interstitial lung disease (ILD) was confirmed in line with the criteria of the American Thoracic Society (ATS)
- ⁶⁸Ga-FAPI and ¹⁸F-FDG PET/CT scans were performed in the Department of Nuclear Medicine.
- Exclusion Criteria: Patients with other connective tissue diseases.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Observe the medical imagesObserve the medical images via work station or local image analysing software | Other | ILD, non-ILD |
| Extracting image featureExtracting image feature via radiomics or machine learning methods | Other | ILD, non-ILD |
Primary outcome
Imaging features of 68Ga-FAPI PET image
Time frame: baseline
conventional PET parameters (SUVmax, SUVmin) and PET textural feature parameters (radiomics)
1 secondary outcome
Performance of Machine Learning and Reference Models
Time frame: baseline
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis (DM) and ILD, run by Ruijin 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 0 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging features of 68Ga-FAPI PET image (time frame: baseline). 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 15 Apr 2026.