Retrospective Multicenter Study of Patient-level T1CE/FLAIR MRI Deep Learning to Predict EGFR/ALK Driver Status in NSCLC Brain Metastases With External Validation and Survival Analysis

Sponsor
Ming Yang
Study ID
NCT07373951
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This retrospective multicenter observational study aims to develop and externally validate a noninvasive deep learning model based on routine brain MRI to identify actionable driver alterations in patients with non-small cell lung cancer (NSCLC) brain metastases. The model uses contrast-enhanced T1-weighted imaging (T1CE) and FLAIR sequences to classify patients as driver-positive (EGFR mutation and/or ALK rearrangement/fusion) versus driver-negative (EGFR-negative and ALK-negative), using brain metastasis tissue next-generation sequencing as the reference standard. The development and internal validation cohorts are from the National Cancer Center (China). Two independent external test cohorts are used: one from the First Affiliated Hospital of Anhui Medical University (China) and one from a public de-identified dataset hosted by The Cancer Imaging Archive (TCIA). The primary endpoint is the patient-level area under the receiver operating characteristic curve (AUC) in the external test cohorts. Secondary analyses include model calibration and decision-curve analysis to estimate clinical utility, comparisons of 2D/2.5D/3D modeling strategies and multimodal fusion approaches, and exploratory associations between model outputs and overall survival (OS) and progression-free survival (PFS), calculated from the date of brain metastasis surgery to the event or last follow-up (data cutoff: May 1, 2026).

Key Dates

First listed
Jan 28, 2026
Start date
Nov 1, 2025
Status verified
Jan 2026
Primary completion
Apr 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
380 participants (estimated)

Arms

  • Arm: National Cancer Center (NCC) Development Cohort
    Retrospective cohort of NSCLC brain metastasis patients from the National Cancer Center (China) with preoperative brain MRI including T1CE and FLAIR and brain metastasis tissue NGS (NCG/NGS) results for EGFR and ALK. This cohort is used for model development and internal validation, including prespecified threshold selection.
  • Arm: Anhui Medical University 1st Affiliated Hospital External Test Cohort
    Independent retrospective external validation cohort from the First Affiliated Hospital of Anhui Medical University (China) with preoperative T1CE and FLAIR MRI and brain metastasis tissue NGS results for EGFR and ALK. No model training or threshold tuning is performed in this cohort; it is used for locked external testing.
  • Arm: TCIA Public External Test Cohort
    Independent external validation cohort obtained from The Cancer Imaging Archive (TCIA), consisting of de-identified public brain MRI data (including T1CE and FLAIR when available) from NSCLC brain metastasis patients. This cohort is used only for locked external testing and is not involved in any model training, tuning, or threshold selection.

Primary Outcome Measure

Patient-level AUC for driver status (External Validation) [ Time Frame: Retrospective analysis through data cutoff (May 1, 2026) ]

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