This phase II trial tests how well increased magnetic resonance imaging (MRI) surveillance works in reducing the rate of symptomatic cancer that has spread to the brain (brain metastasis) in patients treated with radiation therapy for stage III non-squamous non-small cell lung cancer (NSCLC) that has spread to nearby tissue or lymph nodes (locally advanced). An MRI allows doctors to see and take pictures of the brain. MRI is a form of imaging that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The technique is valuable for the diagnosis of many pathologic conditions, including metastatic disease. During the MRI, patients may receive an injection of a chemical called gadolinium. This is called a contrast agent and helps to see parts of the brain better. Researchers want to learn if increasing surveillance of the brain using MRI after radiation therapy will allow them to find brain metastasis before it causes symptoms.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05692635.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Michael K. Farris
Phone: 336-713-3600
PRIMARY OBJECTIVE:
I. To evaluate whether additional follow up brain MRI in patients with non-squamous stage III NSCLC who were previously treated with curative intent radiation therapy (RT) reduces the rate of symptomatic brain metastasis presentation as compared to historical controls.
SECONDARY OBJECTIVES:
I. To estimate time to brain failure in patients with non-squamous stage III NSCLC previously treated with curative intent RT who undergo additional surveillance brain MRIs.
II. To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III NSCLC previously treated with curative intent RT who undergo additional surveillance brain MRIs.
EXPLORATORY OBJECTIVES:
I. To describe the types of therapeutic interventions for detected brain metastases in patients with non-squamous stage III NSCLC previously treated with curative intent RT who undergo additional surveillance brain MRIs.
II. To evaluate symptom severity and interference as measured by MD Anderson Symptom Inventory Brain Tumor (MDASI BT) across the study duration and explore differences in scores between patients who develop brain metastases that are detected as a result of scheduled study MRI versus (vs) those patients where brain metastases are discovered as part of standard of care.
III. Evaluate quality of life as measured by Functional Assessment of Cancer Therapy General (FACT-G) across study duration in patients with non-squamous stage III NSCLC previously treated with curative intent RT who undergo additional surveillance brain MRI.
IV. Explore associations between blood biomarkers and development of brain metastases in patients with non-squamous stage III NSCLC previously treated with curative intent RT who undergo additional surveillance brain MRI.
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.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMichael K. Farris
