NCT07373951Enrolling by invitation
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
Retrospective Multicenter Study: Patient-level Noninvasive Prediction of Non-small Cell Lung Cancer Brain Metastases Based on T1CE and FLAIR Multimodal MRI Deep Learning Models, With Targeted Drivers (EGFR or ALK), External Validation, and Survival Translation Assessment.
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 380 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Ming Yang
- Diseases
- Lung cancer
- NCT number
- NCT07373951
What you commit to
- Study type: Observational
- Planned participants: 380
- From 1 Nov 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- Missing or unverifiable molecular testing results for EGFR and/or ALK from brain metastasis tissue.
Other
- Missing required MRI sequences (T1CE or FLAIR) or non-diagnostic image quality due to severe artifacts/motion.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.