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MRI Surveillance for Brain Metastases from Lung Cancer
Phase 2
Recruiting
Led By Michael Farris, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at using MRI to detect cancer spread to the brain before it causes symptoms.
Who is the study for?
This trial is for adults over 18 with non-squamous locally advanced lung cancer (stages IIIA-IIIC). They must have started radiation therapy within the past 120 days and be able to undergo MRI scans. Pregnant or breastfeeding individuals, those with known brain metastases, or women of childbearing potential not on contraception are excluded.
What is being tested?
The study tests whether regular MRI brain scans after radiation therapy can detect cancer spread to the brain earlier than usual. Participants will receive MRIs using Gadolinium contrast, complete quality of life questionnaires, and provide blood samples.
What are the potential side effects?
Potential side effects may include discomfort from blood draws, allergic reactions to Gadolinium contrast used in MRIs (such as headache or nausea), and anxiety or discomfort from frequent MRI procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is identified as adeno-squamous or mainly squamous.
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I can care for myself but may not be able to do heavy physical work.
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I am 18 years old or older.
Select...
My lung cancer is at an advanced stage but has not spread beyond my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
Secondary study objectives
Collection of Information to Document Brain Metastasis(es) - Number of Metastases
Collection of Information to Document Brain Metastasis(es) - Size of Metastases
Collection of Information to Document Brain Metastasis(es) - Volume of Metastases
+1 moreOther study objectives
Comparison of Exosome Measurements Between Participants
Frequency of Brain Metastasis(es) Directed Interventions
Percentage of Brain Metastasis(es) Directed Interventions
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Surveillance MRI of the BrainExperimental Treatment4 Interventions
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadolinium
2006
Completed Phase 4
~620
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,245 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,023 Total Patients Enrolled
Michael Farris, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
6 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is identified as adeno-squamous or mainly squamous.I am not pregnant and have taken a test to confirm this within the last 14 days.I will have my first brain MRI within 130 days of starting radiation for my lung cancer.I can care for myself but may not be able to do heavy physical work.I am 18 years old or older.My lung cancer is at an advanced stage but has not spread beyond my lungs.You have been diagnosed with brain metastases through an MRI scan.Your kidney function, measured by something called the "EGFR," needs to be higher than a certain level.If you have unusual test results that might be related to blood vessel problems, stroke, or spreading cancer, it won't stop you from joining the study. However, any follow-up tests that were recommended for those issues won't be affected by this study, and the tests for this study won't count as official follow-up scans for those issues.
Research Study Groups:
This trial has the following groups:- Group 1: Surveillance MRI of the Brain
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.