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

Inclusion criteria

1- Age: Participants must be aged 18 years or older. 2、Diagnosis: Patients must have a histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with clinically or pathologically confirmed leptomeningeal metastases (LM), and at least one measurable lesion.

3、Lumbar Puncture and Intrathecal Chemotherapy: Patients must have undergone lumbar puncture and intrathecal chemotherapy in the study center.

4、ECOG Performance Status: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3.

5、Blood Tests: Neutrophil count ≥ 1.5 × 10⁹/L. Hemoglobin ≥ 9 g/dL. Platelet count ≥ 100 × 10⁹/L. 6、Biochemical Tests: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times ULN.

Creatinine clearance ≥ 60 ml/min. 7、No Significant Bleeding or Thrombosis: Patients must not have significant bleeding symptoms, bleeding disorders, or active thrombosis.

8、Reproductive Health: Women of childbearing age must use appropriate contraception and have a negative pregnancy test prior to enrollment.

9、Informed Consent: All patients must have signed the informed consent form and be willing to comply with the study procedures and follow-up schedule.

Exclusion criteria

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

2、Recent Radiotherapy: Patients who have received local radiotherapy for intracranial lesions within the past two weeks are excluded.

3、ECOG Performance Status: Patients with an ECOG performance score greater than 3 are excluded.

4、Uncontrolled Seizures: Patients with uncontrolled seizures are excluded. 5、Other Tumor History: Patients with a current or past history of other tumors are excluded.

6、Bleeding or Thrombotic Disorders: Patients with known hereditary or acquired bleeding or thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia) or with abnormal coagulation function (INR > 2.0, PT > 16s) are excluded. Those on thrombolytic or anticoagulant therapy are also excluded, except for patients on preventive doses of low-dose aspirin or low-molecular-weight heparin.

7、Recent Trauma or Surgery: Patients with a history of severe trauma or surgery within the last month, or significant bleeding events within the past three months, are excluded.

8、Severe Organ Dysfunction: Patients with severe hepatic or renal dysfunction, HIV infection, HCV infection, asthma, or uncontrolled cerebrovascular disease are excluded.

9、Pregnancy and Breastfeeding: Pregnant or breastfeeding women are excluded. Women of childbearing age must test negative for pregnancy within seven days prior to enrollment.

10、Thrombotic Events: Patients with arterial or venous thrombotic events (e.g., stroke, transient ischemic attack, brain hemorrhage, deep vein thrombosis, or pulmonary embolism) within the past six months are excluded.

11、Safety Concerns: Any other conditions or factors that the investigator deems unsuitable for inclusion, including issues that might compromise the patient's safety or compliance, will result in exclusion.