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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07107035
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	AI (Artificial Intelligence), NSCLC Brain Metastasis

Arms & Interventions

Arms

: Construction of AI models (retrospective cohort)

: Validation of AI models (prospective cohort)

Interventions

Other: - No Intervention: Observational Cohort

No intervention

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zhengfei Zhu, PhD

[email protected]

+8618017312901

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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