Multicenter Prospective Validation of AI Models for Malignancy Risk Prediction in Pulmonary Nodules
Condition(s) studied
Study summary
This multicenter prospective diagnostic accuracy study will compare the performance of three artificial intelligence (AI) models (MVCS, LungDoc, and a United Imaging AI model) for predicting the malignancy risk of pulmonary nodules on chest CT. All enrolled patients will have pulmonary nodules ≤3 cm on CT and a definitive postoperative or biopsy pathological diagnosis. The AI models will generate continuous malignancy probability scores based only on CT images. Pathology will serve as the gold standard.
The primary objective is to compare the area under the receiver operating characteristic curve (AUC) for malignancy prediction among the three AI models. Secondary objectives include comparison of sensitivity, specificity, positive and negative predictive values, accuracy, F1 score, and calibration. Exploratory analyses will evaluate the MVCS model for predicting pathological invasion degree (pre-invasive, minimally invasive, and invasive adenocarcinoma) and an extended MVCSN model that incorporates clinical and imaging features in a data-complete subset.
Eligibility
Primary outcome measure(s)
- Area Under the ROC Curve (AUC) for Malignancy Prediction — At the time of availability of pathology results, up to 6 months after index chest CT
For each pure imaging AI model (MVCS, LungDoc, United Imaging model), the AUC of the receiver operating characteristic curve for predicting malignant versus benign pulmonary nodules, based on continuous malignancy probabilities or suspicion scores. AUCs will be reported with 95% confidence intervals, and pairwise comparisons will be conducted using DeLong's test.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Chongqing | Chongqing Municipality | |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | |
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong | |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | |
| Zhejiang University | Hangzhou | Zhejiang |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07727122 on ClinicalTrials.gov ↗ ← All trials in China