Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635 | Recruiting Phase 2 DMC FDA Device

• 3 other identifiers: IRB00092171WFBCCC 99522P30CA012197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form

  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

  At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

Secondary Outcomes (4)

• Time to Brain Failure

  At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

• Collection of Information to Document Brain Metastasis(es) - Number of Metastases

  At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

• Collection of Information to Document Brain Metastasis(es) - Volume of Metastases

  At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

• Collection of Information to Document Brain Metastasis(es) - Size of Metastases

  At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

Other Outcomes (4)

• Quality of Life - The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

  At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

• The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) Questionnaire

  At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

• Comparison of Exosome Measurements Between Participants

  At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment

Study Arms (1)

Surveillance MRI of the Brain

EXPERIMENTAL

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

Diagnostic Test: MRI of the Brain; Other: Blood draws; Other: Quality of Life Questionnaires; Drug: Gadolinium

Interventions

Blood draws OTHER

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

Surveillance MRI of the Brain

Quality of Life Questionnaires 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.

Surveillance MRI of the Brain

Gadolinium DRUG

Given intravenously

Surveillance MRI of the Brain

MRI of the Brain DIAGNOSTIC_TEST

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

Surveillance MRI of the Brain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known brain metastases on staging MRI.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection; Gadolinium

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Michael Farris, MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

336-713-0901; Jada.Kluttz@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 20, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)