Recruiting
Phase 2

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05692635

Conditions

Brain Metastases

Nonsmall Cell Lung Cancer Stage III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI of the Brain

Blood draws

Quality of Life Questionnaires

Gadolinium

Study Details

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.

Conditions

Brain Metastases

Nonsmall Cell Lung Cancer Stage III

Study ID

NCT05692635

Start date

Aug 30, 2023

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

MRI of the Brain

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

Blood draws

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

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.

Gadolinium

Given intravenously

Primary outcome measure

  • Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form [ Time Frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment ]

Central Contacts and Locations

Central contacts

Deonna Asbury

+13367137749Deonna.Asbury@advocatehealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Study Nurse

336-713-7748

Principal Investigator:

Michael Farris, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-17.