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

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method to predict increased pressure inside the skull (intracranial pressure) in patients with lung cancer that has spread to the membranes around the brain (leptomeningeal metastasis). Researchers are using advanced technology called artificial intelligence to analyze ultrasound videos of the optic nerve sheath, which is a part of the eye connected to the brain. The goal is to develop a tool that can help doctors identify and manage complications related to high intracranial pressure more accurately and earlier, potentially improving the care and outcomes for these patients.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of non-small cell lung cancer with leptomeningeal metastases. They should have undergone specific treatments like a lumbar puncture (a procedure to collect spinal fluid) and be in a certain range of health according to a performance status scale (ECOG score of 3 or less). Participants will need to provide informed consent and may undergo additional tests to ensure they are eligible. This trial is not yet recruiting participants, but it holds promise for enhancing the treatment and management of lung cancer patients facing these serious complications.

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ALL

Eligibility criteria

• 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.