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Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05692635•Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years of age.
•Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.
•Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
•Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/- 10 days of their first treatment of radiation therapy for their locally advanced lung cancer. The first radiation treatment is defined as day 1.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
•Epidermal growth factor receptor (EGFR) \> 30 mL/min/1.73m2.
•Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic resonance safety officer, and/or a radiologist as indicated in the form.

Exclusion Criteria

•Known brain metastases on staging MRI.
•Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The recommended follow-up imaging for such findings should have no bearing on the imaging schedule in this protocol, and this research protocol imaging should NOT serve as an official follow-up scan for such findings.
•Patients who are pregnant or breastfeeding.
•Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure, they will not require a pregnancy test. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Key Dates

Start Date

August 30, 2023

Primary Completion Date

April 1, 2028

Completion Date

April 1, 2028

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Brain MetastasesNonsmall Cell Lung Cancer Stage III

Interventions

MRI of the Brain

DIAGNOSTIC_TEST

Blood draws

OTHER

Quality of Life Questionnaires

OTHER

Gadolinium

DRUG

Contacts

Study Coordinator

CONTACT

336-713-0901 Jada.Kluttz@wakehealth.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Inclusion Criteria

Exclusion Criteria

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