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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
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.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGChange in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
Symptomatic brain metastasis presentation (yes or no) will be determined for each participant. Symptomatic brain metastasis presentation anytime during follow-up will be considered a YES. Asymptomatic presentation and death during follow-up without symptomatic presentation will be considered a NO. Patients with incomplete follow-up for reasons other than death will be excluded from the analysis. The proportion with symptomatic presentation will be calculated, and compared to the historical rate of 24% using a one-sample proportion test. A symptomatic brain metastasis presentation is defined as imaging demonstrating evidence of brain metastasis(es) and a change in any given central nervous system symptom. Questions require a YES or NO answer related to symptoms. Questions that are answered YES more often would indicate a unfavorable change in central nervous system symptoms
Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Time to Brain Failure
Time to brain failure will be defined as time in days from the start of radiation therapy to any brain failure. Time to brain failure will be estimated using the method of Kaplan and Meier. Median time to brain failure will be reported along with a 95% confidence interval.
Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Collection of Information to Document Brain Metastasis(es) - Number of Metastases
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Collection of Information to Document Brain Metastasis(es) - Volume of Metastases
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Given intravenously
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Collection of Information to Document Brain Metastasis(es) - Size of Metastases
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment