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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

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 below
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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.
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My lung cancer is at an advanced stage but has not spread beyond my lungs.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment for reporting.

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 more
Other study objectives
Comparison of Exosome Measurements Between Participants
Frequency of Brain Metastasis(es) Directed Interventions
Percentage of Brain Metastasis(es) Directed Interventions
+2 more

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
1,266 Previous Clinical Trials
1,013,647 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,940 Total Patients Enrolled
Michael Farris, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
6 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

MRI of the Brain Clinical Trial Eligibility Overview. Trial Name: NCT05692635 — Phase 2
Brain Tumor Research Study Groups: Surveillance MRI of the Brain
Brain Tumor Clinical Trial 2023: MRI of the Brain Highlights & Side Effects. Trial Name: NCT05692635 — Phase 2
MRI of the Brain 2023 Treatment Timeline for Medical Study. Trial Name: NCT05692635 — Phase 2
~21 spots leftby May 2025