Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Trial Title: Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT ID: NCT05692635

Condition: Brain Metastases
Nonsmall Cell Lung Cancer Stage III

Conditions: Official terms:
Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Carcinoma, Non-Small-Cell Lung

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: MRI of the Brain
Description: An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
Arm group label: Surveillance MRI of the Brain

Intervention type: Other
Intervention name: Blood draws
Description: Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
Arm group label: Surveillance MRI of the Brain

Intervention type: Other
Intervention name: Quality of Life Questionnaires
Description: 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.
Arm group label: Surveillance MRI of the Brain

Intervention type: Drug
Intervention name: Gadolinium
Description: Given intravenously
Arm group label: Surveillance MRI of the Brain

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Wake Forest Baptist Comprehensive Cancer Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Status: Recruiting

Contact:
Last name: Study Nurse

Phone: 336-713-7748

Investigator:
Last name: Michael Farris, MD
Email: Principal Investigator

Start date: August 30, 2023

Completion date: August 2025

Lead sponsor:
Agency: Wake Forest University Health Sciences
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Wake Forest University Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05692635