AI-Based Ultrasound Prediction Model for Intracranial Pressure and Prognosis in Lung Cancer Patients With Leptomeningeal Metastasis: A Dual-Center Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

This study focuses on developing an innovative, artificial intelligence-based model using optic nerve sheath ultrasound videos to predict intracranial pressure in lung cancer patients with leptomeningeal metastasis. The study also aims to create a multimodal clinical prognosis model that can help improve patient outcomes. By analyzing ultrasound data from patients at two major medical centres, the research seeks to provide more accurate and early predictions of complications related to elevated intracranial pressure, ultimately improving treatment and management strategies for these patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1、Histological Type: Patients with squamous cell carcinoma or small cell lung cancer are excluded.

Trial population

1. Primary Diagnosis: Patients diagnosed with non-small cell lung cancer (NSCLC), confirmed through histopathological examination. 2. Leptomeningeal Metastases (LM): Patients with clinically or pathologically confirmed LM, a serious complication of NSCLC characterized by cancer spread to the membranes surrounding the brain and spinal cord. 3. Age Range: Patients aged 18 years or older. 4. ECOG Performance Status: Patients must have an ECOG score of 3 or lower, indicating varying degrees of functionality but generally not bedridden. 5. Intrathecal Chemotherapy: The study focuses on patients undergoing lumbar puncture and intrathecal chemotherapy as part of their treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Accuracy of the Intracranial Pressure (ICP) Prediction Model and Efficacy of the Prognostic Model

Accuracy of the Intracranial Pressure (ICP) Prediction Model: This involves constructing a prediction model for ICP based on optic nerve sheath diameter (ONSD) and other ultrasound measurements (e.g., optic disk height, ODH). The model's accuracy will be evaluated by comparing the predicted ICP values with those obtained through lumbar puncture, using metrics such as the area under the ROC curve (AUC), sensitivity, and specificity. Efficacy of the Prognostic Model: This model will predict clinical outcomes such as progression-free survival (PFS) and overall survival (OS) based on multimodal data, including clinical and imaging data. The predictive performance will be assessed using the C-index and other statistical measures to determine its effectiveness in forecasting patient outcomes.

Time frame
Half an hour before the lumbar puncture

Secondary outcomes

Other outcomes

Sponsors and contacts

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Nanjing University

Collaborator

Nanjing Jiangning Hospital

Collaborator

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