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临床试验/NCT06285058
NCT06285058尚未招募不适用

A Artificial Intelligence Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy

Wuhan Union Hospital, China0 个研究点目标入组 1,000 人开始时间: 2024年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model

研究概览

简要总结

This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy.

详细描述

This study retrospectively obtained non-contrast enhanced and contrast enhanced CT scans of patients with NSCLC who underwent surgery after receiving neoadjuvant immunochemotherapy. at multiple centers between August 2019 and February 2023. Deep learning features were extracted from both non-contract enhanced and contract enhanced CT scans to construct the predictive models (LUNAI-nCT model and LUNAI-eCT model), respectively. After feature fusion of these two types of features, a fused model (LUNAI-fCT model) was constructed. The performance of the model was evaluated using the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). SHapley Additive exPlanations (SHAP) analysis was used to quantify the impact of CT imaging features on model prediction. To gain insights into how our model makes predictions, we employed Gradient-weighted Class Activation Mapping (Grad-CAM) to generate saliency heatmaps.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' with non-small cell lung cancer, diagnosed through biopsy pathology and clinically classified as stage IB to III;
  • Patients who receive at least two cycles of neoadjuvant immunotherapy combined with chemotherapy induction therapy;
  • According to the IASLC guidelines, postoperative pathological evaluation was performed on the treatment response of the tumor primary lesion and lymph nodes.

排除标准

  • Missing or inadequate quality of CT;
  • Time interval between CT and start of treatment is greater than 1 month;
  • Incomplete clinicopathologic data.

结局指标

主要结局

the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model

时间窗: Baseline treatment

several metrics were calculated, including accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

次要结局

未报告次要终点

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Sponsor

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