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Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters

Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07531446
Enrollment
200
Registered
2026-04-15
Start date
2026-01-13
Completion date
2027-01-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis (DM), ILD, Machine Learning, Radiomics

Keywords

positron emission tomography/computed tomography, dermatomyositis, ILD, machine learning, radiomics

Brief 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 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.

Interventions

Observe the medical images via work station or local image analysing software

OTHERExtracting image feature

Extracting image feature via radiomics or machine learning methods

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The diagnosis of dermatomyositis (DM) was made in accordance with the Bohan and Peter criteria 2. The diagnosis of clinically amyopathic dermatomyositis (CADM) was established based on the Sontheimer criteria 3. The diagnosis of interstitial lung disease (ILD) was confirmed in line with the criteria of the American Thoracic Society (ATS) 4. ⁶⁸Ga-FAPI and ¹⁸F-FDG PET/CT scans were performed in the Department of Nuclear Medicine.

Exclusion criteria

Patients with other connective tissue diseases.

Design outcomes

Primary

MeasureTime frameDescription
Imaging features of 68Ga-FAPI PET imagebaselineconventional PET parameters (SUVmax, SUVmin) and PET textural feature parameters (radiomics)

Secondary

MeasureTime frameDescription
Performance of Machine Learning and Reference ModelsbaselineROC curve (Receiver Operating Characteristic curve)、DCA curve (Decision Curve Analysis curve)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026