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Clinical Trials/NCT06285058
NCT06285058
Not yet recruiting
Not Applicable

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

Wuhan Union Hospital, China0 sites1,000 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Learning Model
Sponsor
Wuhan Union Hospital, China
Enrollment
1000
Primary Endpoint
the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
March 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wuhan Union Hospital, China
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline treatment

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

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