Clinical trial · Observational
Annual Brain MRI Surveillance for Detection of Brain Metastasis in Patients With Lung Cancer
Effectiveness of Annual Brain Magnetic Resonance Imaging Surveillance for Detection of Brain Metastasis and Survival Outcomes in Patients With Lung Cancer: A Nationwide Sequential Target Trial Emulation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective observational study will evaluate the effectiveness of periodic brain magnetic resonance imaging surveillance for detecting brain metastasis in patients with lung cancer. Using linked nationwide claims and cancer registry data from Korea, the study will emulate a sequence of monthly target trials among patients with newly diagnosed lung cancer and no prior brain metastasis. At each monthly trial, eligible patients will be classified according to whether they receive active brain MRI surveillance or remain in an inactive surveillance state. The main analysis will define the active surveillance period as one year after brain MRI. A sensitivity analysis will define the active surveillance period as two years. Patients may re-enter later trials if they again become eligible. Patients will be excluded from a given trial if they have recent neurologic symptoms suggesting diagnostic MRI, prior brain MRI within the preceding surveillance interval, brain metastasis, or death. The primary objective is to assess whether annual brain MRI surveillance increases detection of brain metastasis. Secondary objectives are to evaluate whether surveillance-detected brain metastases are more likely to be asymptomatic or potentially treatable, and whether surveillance-detected brain metastasis is associated with lower mortality among patients who develop brain metastasis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasases | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| MRI | — | UNRESOLVED | — |
| Surveillance | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Active Brain MRI Surveillance
- description
- Patients classified as receiving active brain MRI surveillance during an emulated monthly trial. In the primary analysis, active surveillance status will be maintained for one year after a surveillance brain MRI. In the sensitivity analysis, active surveillance status will be maintained for two years after brain MRI. Patients may return to the inactive surveillance state after the active surveillance period unless another surveillance MRI is performed.
- label
- Inactive Brain MRI Surveillance
- description
- Patients who are eligible for an emulated monthly trial but are not in an active brain MRI surveillance period. Patients in this group may later enter the active surveillance group if they undergo surveillance brain MRI in a subsequent monthly trial.
Primary outcomes (1)
- measure
- Incident brain metastasis.
- timeFrame
- From each monthly trial baseline to incident brain metastasis, death, censoring, or end of follow-up, whichever occurs first (max 10 years).
- description
- Incident brain metastasis will be defined as a new diagnosis code for brain metastasis after trial baseline among patients without prior brain metastasis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients will be eligible if they have newly diagnosed lung cancer between 2012 and 2021 Exclusion Criteria: * Prior brain MRI within the preceding within 1 year * Incident brain metastasis before trial entry. * Recent neurologic symptoms, emergency department use, hospital admission, neurologic consultation, or prescriptions for dexamethasone, mannitol, levetiracetam, or valproate within prespecified time windows around the MRI date.
References
Publications (0)
Data not yet available