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Not yet recruitingNCT07107035Updated Aug 6, 2025

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

An observational study in AI (Artificial Intelligence) and NSCLC Brain Metastasis, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-06.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years and older
Sex
All
01

Study 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).

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
02

Conditions studied

  • AI (Artificial Intelligence)
  • NSCLC Brain Metastasis
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are collected all over China

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Construction of AI models (retrospective cohort)

    Other: No Intervention: Observational Cohort

  • Validation of AI models (prospective cohort)

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No intervention

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 2 years

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 2 years

  2. Intracranial Progression-Free Survival (iPFS)

    Time frame: 2 years

  3. Overall Survival (OS)

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07107035
Lead sponsor
Fudan University
Responsible party
Zhengfei Zhu (Professor, Fudan University) — Principal investigator
First posted
Aug 6, 2025
Start date
Sep 2025 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Jul 2030 (estimated)
Last update
Aug 6, 2025

Study contacts

Zhengfei Zhu, PhD
Contact
fuscczzf@163.com
+8618017312901

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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