AI (Artificial Intelligence)NCT07107035
Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer
An observational study of AI (Artificial Intelligence) and NSCLC Brain Metastasis, run by Fudan University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AI (Artificial Intelligence), NSCLC Brain Metastasis
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jul 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are collected all over China
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer: A Nationwide, Multicenter, Observational Study
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:
Read more
- 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
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Construction of AI models (retrospective cohort) | Not described Receives: Other: No Intervention: Observational Cohort | |
| Validation of AI models (prospective cohort) | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive performance of the multimodal large models
Including Sensitivity (SEN), Specificity (SPE), Matthews Correlation Coefficient (MCC), Area Under the Receiver Operating Characteristic Curve (AUC) with its corresponding 95 % confidence interval (CI)
Measured: 2 years
Secondary outcomes (3)
Progression-Free Survival (PFS)
Measured: 2 years
Intracranial Progression-Free Survival (iPFS)
Measured: 2 years
Overall Survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI (Artificial Intelligence)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107035
- Sponsor's protocol ID
- LCBM-AI
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer: A Nationwide, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT07107035
- Acronym / sponsor ID
- LCBM-AI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Aug 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Construction of AI models (retrospective cohort) | – | Other: No Intervention: Observational Cohort |
| Validation of AI models (prospective cohort) | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are collected all over China
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Construction of AI models (retrospective cohort), Validation of AI models (prospective cohort) |
Primary outcome
The predictive performance of the multimodal large models
Time frame: 2 years
Including Sensitivity (SEN), Specificity (SPE), Matthews Correlation Coefficient (MCC), Area Under the Receiver Operating Characteristic Curve (AUC) with its corresponding 95 % confidence interval (CI)
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years
Intracranial Progression-Free Survival (iPFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
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 6 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of AI (Artificial Intelligence) and NSCLC Brain Metastasis, run by Fudan University.
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 6 inclusion and 4 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhengfei Zhu, PhD (+8618017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive performance of the multimodal large models (time frame: 2 years). 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 6 Aug 2025.