Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Official title

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer

Overview

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

Interventions

• Diagnostic test MRI of the Brain
  An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
• Other Blood draws
  Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
• Other 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.
• Drug Gadolinium
  Given intravenously

Primary outcome measures

• 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]

Secondary outcome measures (4)

• Time to Brain Failure [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT05692635 · IRB00092171 · WFBCCC 99522 · P30CA012197

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗