Actively Recruiting
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients with Brain Metastases
Led by Fudan University · Updated on 2024-11-12
800
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced non-small cell lung cancer (NSCLC) patients who have brain metastases and carry specific EGFR mutations. The study aims to use deep learning to analyze imaging features from brain and lung lesions, along with clinical data, to build a model that predicts how well patients respond to third-generation EGFR-TKI treatments and their survival. This model will also help identify patients who may benefit from early cranial radiotherapy. Participants in this observational study are receiving first-line treatment with third-generation EGFR-TKIs such as Almonertinib, Furmonertinib, or Osimertinib, either alone or combined with upfront cranial radiotherapy. The study involves collecting regular contrast-enhanced chest CT scans and brain MRI images to construct and validate the AI-based prediction model using both retrospective and prospective patient data. During the study, researchers will monitor patient outcomes including progression-free survival, intracranial response rates, and overall survival over one year. Participants will undergo standard imaging and clinical follow-up assessments, and their data will help evaluate the model's ability to guide treatment decisions. The total study duration includes follow-up periods to assess treatment efficacy and safety.
CONDITIONS
Brief Title
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed non-small cell lung cancer
- Clinical stage IV according to AJCC 8th edition (2017)
- Presence of EGFR sensitive mutations: EGFR L858R or EGFR exon 19 deletion
- Age 18 years or older
- Karnofsky Performance Status (KPS) score of 70 or higher
- Brain metastases present at diagnosis
- Complete systemic imaging including brain MRI before starting third-generation EGFR-TKI treatment
- Receiving standard first-line third-generation EGFR-TKI therapy, alone or combined with brain radiotherapy
- Willingness to cooperate with follow-up after treatment
- Provided informed consent
You will not qualify if you...
- Multiple primary or metastatic tumors, except treated early skin cancer or cervical carcinoma in situ without recurrence for over 5 years
- Pregnant or lactating women not suitable for brain MRI as judged by investigator
- Negative EGFR sensitive mutations or unknown EGFR mutation status
- Uncontrolled epilepsy, central nervous system diseases, or history of mental disorders that may affect consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies depending on treatment duration
Participants receive first-line third-generation EGFR-TKI treatment, either alone or combined with upfront cranial radiotherapy.
Duration - Up to 1 year
Participants are followed up to monitor progression-free survival and other outcomes after treatment.
Trial Site Locations
Total: 1 location
1
Shanghai Cancer center
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
Research Team
Z
zhengfei Zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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