Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Last updated: March 19, 2026
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Brain Metastases

Treatment

Blood draws

MRI of the Brain

Quality of Life Questionnaires

Clinical Study ID

NCT05692635
IRB00092171
WFBCCC 99522
P30CA012197
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years of age.

  • Patients with non-squamous locally advanced lung cancer defined by American JointCommittee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.

  • Histology described as adeno-squamous or not otherwise specified favoring squamousare eligible.

  • Patients may be enrolled before or after the start of radiation therapy but must beenrolled and have their first surveillance MRI brain at 120 +/- 10 days of theirfirst treatment of radiation therapy for their locally advanced lung cancer. Thefirst 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 screeningchecklist questionnaire. This will be completed by a MRI imaging technician,enrolling physician, CPDM staff member, a magnetic resonance safety officer, and/ora radiologist as indicated in the form.

Exclusion

Exclusion Criteria:

  • Known brain metastases on staging MRI.

  • Questionable findings that may represent a differential of vasculatureabnormalities/stroke/ and or metastatic disease with recommended short intervalfollow-up are not an exclusion factor for study participation. The recommendedfollow-up imaging for such findings should have no bearing on the imaging schedulein this protocol, and this research protocol imaging should NOT serve as an officialfollow-up scan for such findings.

  • Patients who are pregnant or breastfeeding.

  • Premenopausal persons of childbearing potential must have a negative pregnancy testwithin 14 days of enrollment. If women are not of childbearing potential as definedby women who are menopausal female or has had a hysterectomy, bilateraloophorectomy, or medically-documented ovarian failure, they will not require apregnancy test. Should a woman become pregnant or suspect she is pregnant while sheor her partner is participating in this study, she should inform her treatingphysician immediately.

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Blood draws
Phase: 2
Study Start date:
August 30, 2023
Estimated Completion Date:
April 30, 2028

Study 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

Connect with a study center

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

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