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

NCT07531446 | Active Not Recruiting DMC

• 1 other identifier: RuijinH 2026-47
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatomyositis (DM); ILD; Machine Learning; Radiomics

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Imaging features of 68Ga-FAPI PET image

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

  baseline

Secondary Outcomes (1)

• Performance of Machine Learning and Reference Models

  baseline

Other Outcomes (3)

• SHAP Analysis of the Optimal Model

  baseline

• Between-group Differences

  baseline

• Correlation analysis

  baseline

Study Arms (2)

ILD

The diagnosis of ILD was confirmed in line with the criteria of the American Thoracic Society (ATS).

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.

Other: Observe the medical images; Other: Extracting image feature

Interventions

Observe the medical images OTHER

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

ILD; non-ILD

Extracting image feature OTHER

Extracting image feature via radiomics or machine learning methods

ILD; non-ILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 15, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)