Back to resultsReducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Primary Purpose
Brain Metastases, Nonsmall Cell Lung Cancer Stage III
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRI of the Brain
Blood draws
Quality of Life Questionnaires
Gadolinium
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases
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 no later than 90 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.
Sites / Locations
- Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surveillance MRI of the Brain
Arm Description
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to Brain Failure
Time to brain failure will be defined as time in days from the start of radiation therapy to any brain failure. Time to brain failure will be estimated using the method of Kaplan and Meier. Median time to brain failure will be reported along with a 95% confidence interval.
Collection of Information to Document Brain Metastasis(es) - Number of Metastases
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Collection of Information to Document Brain Metastasis(es) - Volume of Metastases
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Collection of Information to Document Brain Metastasis(es) - Size of Metastases
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Full Information
NCT ID
NCT05692635
First Posted
December 7, 2022
Last Updated
October 16, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05692635
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Nonsmall Cell Lung Cancer Stage III
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surveillance MRI of the Brain
Arm Type
Experimental
Arm Description
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI of the Brain
Intervention Description
An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
Intervention Type
Other
Intervention Name(s)
Blood draws
Intervention Description
Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaires
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Intervention Description
Given intravenously
Primary Outcome Measure Information:
Title
Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
Description
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
Time Frame
At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Secondary Outcome Measure Information:
Title
Time to Brain Failure
Description
Time to brain failure will be defined as time in days from the start of radiation therapy to any brain failure. Time to brain failure will be estimated using the method of Kaplan and Meier. Median time to brain failure will be reported along with a 95% confidence interval.
Time Frame
At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
Collection of Information to Document Brain Metastasis(es) - Number of Metastases
Description
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time Frame
At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
Collection of Information to Document Brain Metastasis(es) - Volume of Metastases
Description
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time Frame
At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
Collection of Information to Document Brain Metastasis(es) - Size of Metastases
Description
Information collected related to the time to brain failure will include the number, size and volume of brain metastases) that are documented to help describe changes in symptoms and quality of life. Measurement in days (median) will be estimated along with a 95% confidence interval.
Time Frame
At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Other Pre-specified Outcome Measures:
Title
Frequency of Brain Metastasis(es) Directed Interventions
Description
Types of different interventions for brain metastasis will be collected (this will include interventions such as IV or oral steroid administration for central nervous system symptoms, craniotomy, whole brain radiotherapy, gamma knife radiosurgery, laser interstitial thermal therapy (LITT). Frequencies will be used to describe types of therapeutic interventions for detected brain metastases.
Time Frame
26 months after the start of radiation therapy or until death
Title
Quality of Life - The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Description
The FACT-G is scored on a 5 point Likert-type scale. Scoring range has a possible range of 0-108 points. The total score and four subscale scores (physical well-being, social/family well-being, emotional well-being and functional well-being) will be calculated for each patient at each time point. Descriptive statistics and graphical methods will be used to visualize and describe changes in symptoms and quality of life over time.
Higher scores indicate better quality of life.
Time Frame
At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) Questionnaire
Description
The MDASI-BT consists of 23 symptoms and 6 interference items rated on an 11-point scale (0-10) to indicate the presence and severity of each symptom in the last 24 hours, with 0 being "not present" and 10 being "as bad as you can imagine." A higher score always indicates an increase in severity. The core symptom severity score (13 core symptom), brain tumor symptom severity score (9 brain tumor specific symptoms), total symptom severity (13 core symptoms + 9 brain tumor specific symptoms), and interference score (6 interference items only) will be calculated for each patient at each time point.
Time Frame
At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
Comparison of Exosome Measurements Between Participants
Description
The blood sample taken at the first visit will be used to measure exosomes. T tests or Wilcoxon rank-sum tests will be used to compare exosome measurements between those participants who eventually develop brain metastases and those who do not. Descriptive statistics will be used to characterize changes in exosome measurements over time.
Time Frame
At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Title
Percentage of Brain Metastasis(es) Directed Interventions
Description
Types of different interventions for brain metastasis will be collected (this will include interventions such as IV or oral steroid administration for central nervous system symptoms, craniotomy, whole brain radiotherapy, gamma knife radiosurgery, laser interstitial thermal therapy (LITT). Percentages of will be used to describe types of therapeutic interventions for detected brain metastases.
Time Frame
26 months after the start of radiation therapy or until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 no later than 90 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Nurse
Phone
336-713-7748
Email
saverill@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Farris, MD
Organizational Affiliation
Wake Forest Baptist Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Nurse
Phone
336-713-7748
First Name & Middle Initial & Last Name & Degree
Michael Farris, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
We'll reach out to this number within 24 hrs