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OpenTrials
Active, Not Recruiting

NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine & Institute for medical imaging technology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Observe the medical images

Other

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

Extracting image feature

Other

Extracting image feature via radiomics or machine learning methods

Primary outcomes

  1. Imaging features of 68Ga-FAPI PET image

    Time frame: baseline

    conventional PET parameters (SUVmax, SUVmin) and PET textural feature parameters (radiomics)

Secondary outcomes

  1. Performance of Machine Learning and Reference Models

    Time frame: baseline

    ROC curve (Receiver Operating Characteristic curve)、DCA curve (Decision Curve Analysis curve)

Other outcomes

  1. SHAP Analysis of the Optimal Model

    Time frame: baseline

  2. Between-group Differences

    Time frame: baseline

    DM-ILD and DM non-ILD Group comparison of important parameters in models

  3. Correlation analysis

    Time frame: baseline

    Correlation analysis of the various parameters in the model.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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