Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT ID: NCT05692635

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Surveillance MRI of the Brain

Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.

Group Type: EXPERIMENTAL

MRI of the Brain

Intervention Type: DIAGNOSTIC_TEST

An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.

Blood draws

Intervention Type: OTHER

Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.

Quality of Life Questionnaires

Intervention Type: OTHER

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.

Gadolinium

Intervention Type: DRUG

Given intravenously

Interventions

MRI of the Brain

An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.

Intervention Type: DIAGNOSTIC_TEST

Blood draws

Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.

Intervention Type: 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.

Intervention Type: OTHER

Gadolinium

Given intravenously

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Farris, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

Jada.Kluttz@wakehealth.edu

336-713-0901

Facility Contacts

Study Nurse

Role: primary

336-713-7748

Other Identifiers

WFBCCC 99522

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00092171

Identifier Type: -

Identifier Source: org_study_id