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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 99522 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI of the Brain | Diagnostic Test | An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 336-713-0901 | Jada.Kluttz@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Farris, MD | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood draws | Other | Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes. |
|
| 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. |
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| Gadolinium | Drug | Given intravenously |
|
| 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. | 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 | 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. | 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 | 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. | At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment |
| 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 | 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. | At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment |
| Comparison of Exosome Measurements Between Participants | 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. | At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment |
| Percentage of Brain Metastasis(es) Directed Interventions | 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. | 26 months after the start of radiation therapy or until death |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |