Annual Brain MRI Surveillance for Detection of Brain Metastasis in Patients With Lung Cancer

NCT07646041 | Completed

• 1 other identifier: Brain MRI in Lung Cancer
• Study Type: observational
• Target: 229,323
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer; Brain Metastasases; MRI; Surveillance

Keywords

Lung cancer; Brain metastasis; Brain MRI; Magnetic resonance imaging; Surveillance; Early detection; Target trial emulation

Outcome Measures

Primary Outcomes (1)

• Incident brain metastasis.

  Incident brain metastasis will be defined as a new diagnosis code for brain metastasis after trial baseline among patients without prior brain metastasis.

  From each monthly trial baseline to incident brain metastasis, death, censoring, or end of follow-up, whichever occurs first (max 10 years).

Secondary Outcomes (2)

• Asymptomatic brain metastasis

  From each monthly trial baseline to incident brain metastasis, death, censoring, or end of follow-up, whichever occurs first (max 10 years).

• All-cause mortality among patients with brain metastasis.

  From brain metastasis diagnosis to death, censoring, or end of follow-up, whichever occurs first (max 10 years).

Study Arms (2)

Active Brain MRI Surveillance

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.

Inactive Brain MRI Surveillance

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients with newly diagnosed lung cancer identified from linked nationwide Korean data sources, including the Korean National Health Insurance Service database, the Health Insurance Review and Assessment Service database, and the Korea Central Cancer Registry. Patients diagnosed with lung cancer between 2012 and 2021 will be eligible. Patients with evidence of brain metastasis before or at the time of lung cancer diagnosis will be excluded.

You may qualify if:

• \- Patients will be eligible if they have newly diagnosed lung cancer between 2012 and 2021

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 12, 2026
• Study Start: January 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share