Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Imaging features of 68Ga-FAPI PET image
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with other connective tissue diseases.
研究组 & 干预措施
ILD
The diagnosis of ILD was confirmed in line with the criteria of the American Thoracic Society (ATS).
干预措施: Observe the medical images (Other)
ILD
The diagnosis of ILD was confirmed in line with the criteria of the American Thoracic Society (ATS).
干预措施: Extracting image feature (Other)
non-ILD
Patients in the non-ILD group had no evidence of ILD as judged by ATS criteria.
干预措施: Observe the medical images (Other)
non-ILD
Patients in the non-ILD group had no evidence of ILD as judged by ATS criteria.
干预措施: Extracting image feature (Other)
结局指标
主要结局
Imaging features of 68Ga-FAPI PET image
时间窗: baseline
conventional PET parameters (SUVmax, SUVmin) and PET textural feature parameters (radiomics)
次要结局
- Performance of Machine Learning and Reference Models(baseline)
研究者
Hu Jiajia
Principal Investigator, Clinical Professor
Ruijin Hospital