AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
- Sponsor
- Fudan University
- Study ID
- NCT06604689
- Status
- Recruiting
Conditions
- Brain Metastasases
- NSCLC (Advanced Non-small Cell Lung Cancer)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) — DRUGEGFR-mutated NSCLC patients with brain metastases who met the inclusion and exclusion criteria, would receive first-line third-generation EGFR-TKI treatment (monotherapy or combined with upfront cranial radiotherapy)
Study Details
The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy. Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.
Key Dates
- Start date
- Sep 30, 2024
- Status verified
- Nov 2024
- Primary completion
- Apr 1, 2025
- Completion
- Oct 1, 2025
Study Design
- Enrollment
- 800 participants (estimated)
Arms
- Arm: Construction of AI models (retrospective cohort)
- Arm: Validation of AI models (prospective cohort)
Primary Outcome Measure
Progression-Free Survival (PFS) [ Time Frame: 1 year ]
Central Contacts
- zhengfei Zhu+86-18017312901
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