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RECRUITING

NCT05692635

PHASE2

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-08-30

Completion Date

2028-04

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Brain Metastases Nonsmall Cell Lung Cancer Stage III

Interventions

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

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