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MRI Surveillance for Brain Metastases in Stage III Lung Cancer

This study is looking at whether regular brain MRI scans can help find cancer that has spread to the brain (brain metastases) in people with Stage III non-small cell lung cancer before it causes symptoms. Participants will receive three MRI brain scans with and without gadolinium (a contrast dye given intravenously) and provide blood samples for testing. You will also complete two questionnaires about your quality of life and any symptoms you might have. The study aims to see if this monitoring can reduce the number of people who develop symptomatic brain metastases. To join, you must be at least 18 years old and have Stage IIIA, IIIB, or IIIC non-squamous locally advanced lung cancer.

Study design
This is an interventional study with a planned enrollment of 60 participants. It aims to compare outcomes to historical controls.
What's involved
You will undergo three MRI brain scans, provide blood samples before each MRI, and complete two quality of life questionnaires. These questionnaires will take about 10-15 minutes each.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for approximately 780 days (about 26 months) from your first radiation therapy treatment, or until death, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05692635

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Wake Forest University Health Sciences
~60 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:MRI of the BrainBlood drawsQuality of Life QuestionnairesGadolinium

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
Measured over At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

Conditions

Brain Metastases
Nonsmall Cell Lung Cancer Stage III

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Michael Farris, MD · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Comprehensive Cancer Center

Who to contact

Deonna Asbury
[email protected]
+13367137749
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring FormAt 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

    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