Lung Cancer (NSCLC)NCT07005791
AI-Based Ultrasound Prediction Model for Intracranial Pressure and Prognosis in Lung Cancer Patients With Leptomeningeal Metastasis: A Dual-Center Study
An observational study of Lung Cancer (NSCLC) and Leptomeningeal Metastasis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC), Leptomeningeal Metastasis, Intracranial Pressure
- How many people
- 142 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Jiangning Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210000
Bo Liao, 18851659006, liao2007203077@126.com
Nanjing Drum-tower Hospital Affiliated to Medical College of Nanjing University
Nanjing, Jiangsu, 211199
Cheng Jiang, 15951756001, 15951756001@163.com
About this study
Official title: 基于人工智能的视神经鞘超声视频构建肺癌软脑膜转移患者颅内压预测模型及多模态临床预后模型的双中心临床研究
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.
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Meningeal Carcinomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Half an hour before the lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing University, The Affiliated Jiangning Hospital of Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005791
- Sponsor's protocol ID
- 2024-LCYJ-PY-60
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 基于人工智能的视神经鞘超声视频构建肺癌软脑膜转移患者颅内压预测模型及多模态临床预后模型的双中心临床研究
- ClinicalTrials.gov ID
- NCT07005791
- Acronym / sponsor ID
- 2024-LCYJ-PY-60
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Nanjing University, The Affiliated Jiangning Hospital of Nanjing Medical University
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the Intracranial Pressure (ICP) Prediction Model and Efficacy of the Prognostic Model
Time frame: Half an hour before the lumbar puncture
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC) and Leptomeningeal Metastasis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu (13390799892, cathytina_19820515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Intracranial Pressure (ICP) Prediction Model and Efficacy of the Prognostic Model (time frame: Half an hour before the lumbar puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.