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Not yet recruiting NCT07107035

Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer

Observational AI (Artificial Intelligence) NSCLC Brain Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: AI (Artificial Intelligence), NSCLC Brain Metastasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer: A Nationwide, Multicenter, Observational Study

Overview

The goal of this nationwide, multicenter observational study is to develop and externally validate multimodal large models that can (1) predict the risk of brain metastases and (2) estimate long-term prognosis in patients with non-small cell lung cancer (NSCLC). The main questions it aims to answer are: * Can a multimodal large model that fuses imaging, pathology, genomic, and clinical data accurately identify NSCLC patients at high risk of developing brain metastases? * Can a multimodal large model reliably forecast intracranial progression-free survival, progression-free survival, and overall survival across diverse real-world treatment settings? (ie, patients receiving distinct treatment regimens, in different treatment lines and with or without intracranial local therapies). Because this is an observational study, there are no investigational treatments; instead, researchers will compare outcomes among patients who receive standard-of-care therapies (surgery, radiotherapy, systemic therapy) to determine how well the model's predictions align with observed events. Participants will: * Allow use of their routinely collected clinical information, imaging (chest CT, brain MRI), pathology slides, and molecular test results for model training and validation * Undergo standard-of-care follow-ups * Complete optional quality-of-life questionnaires during scheduled visits

Interventions

  • Other No Intervention: Observational Cohort
    No intervention

Primary outcome measures

  • The predictive performance of the multimodal large models [Time frame: 2 years]
Secondary outcome measures (3)
  • Progression-Free Survival (PFS) [Time frame: 2 years]
  • Intracranial Progression-Free Survival (iPFS) [Time frame: 2 years]
  • Overall Survival (OS) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Age≥18 years old;
  • KPS score≥70;
  • Pathologically confirmed lung cancer;
  • Receiving guideline-concordant standard-of-care therapy, defined as: radical surgical resection for early- to mid-stage non-small cell lung cancer (NSCLC); stereotactic radiotherapy for early-stage NSCLC deemed medically inoperable; radical chemoradiotherapy for locally advanced NSCLC; or systemic therapy for advanced-stage NSCLC.
  • Complete systemic imaging before treatment initiation, including contrast-enhanced brain MRI and contrast-enhanced chest CT;
  • Informed consent of the patient.

Exclusion criteria

  • Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
  • Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;
  • Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of treatment complications
  • Pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07107035 · LCBM-AI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗