NCT05692635

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.

Detailed description

Primary Objective: To evaluate whether additional follow up brain MRI in patients with non-squamous stage III nonsmall cell lung cancer who were previously treated with curative intent radiation therapy reduces the rate of symptomatic brain metastasis presentation as compared to historical controls. Secondary Objectives: * To estimate time to brain failure in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging. * To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging. OUTLINE: Patients undergo MRI with or without gadolinium contrast intravenously (IV) as well as blood sample collection on study. Patients are followed for approximately 780 days from the first treatment of radiation or until death, whichever occurs first

Conditions

• Brain Metastases
• Nonsmall Cell Lung Cancer Stage III

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI of the Brain	An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
OTHER	Blood draws	Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
OTHER	Quality of Life Questionnaires	Participants will fill out two questionnaires about their health. These questionnaires will tell investigators about any symptoms participants may be having that might be related to cancer spreading to their brain. This will take about 10-15 minutes to complete.
DRUG	Gadolinium	Given intravenously

Timeline

• Start date: 2023-08-30
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-01-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study