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
Enrolling by invitation
Conditions studied: Non-Small Cell Lung Cancer, Brain Metastases
In brief
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 facts
- Study ID
- NCT07373951
- Run by
- Ming Yang
- People needed
- 380
- Starts
- 2025-11-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years at the time of brain metastasis surgery. Histologically confirmed non-small cell lung cancer (NSCLC). Brain metastasis treated with surgical resection (index date for survival analyses).
- Preoperative brain MRI is available, including, at minimum, contrast-enhanced T1-weighted imaging (T1CE) and FLAIR.
- EGFR and ALK status are available from next-generation sequencing (NCG/NGS) performed on resected brain metastasis tissue (+/-).
- MRI quality sufficient for analysis (adequate brain coverage and no severe artifacts).
You may not qualify if…
- Missing required MRI sequences (T1CE or FLAIR) or non-diagnostic image quality due to severe artifacts/motion.
- Missing or unverifiable molecular testing results for EGFR and/or ALK from brain metastasis tissue.
- Uncertain primary tumor origin or non-NSCLC histology. Prior intracranial therapy that substantially alters lesion appearance before the index MRI and cannot be reliably ascertained or adjusted for (e.g., radiotherapy immediately before the MRI), as determined by study investigators.
Where it is running
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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