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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

Study 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.Check my eligibility

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.See study design

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 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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form

Secondary outcome measures

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 outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,666 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,072 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved Surveillance MRI of the Brain?

"The safety of Surveillance MRI of the Brain has been assessed by our team at Power and given a rating of 2. This is due to being in Phase 2, meaning there's evidence for its security but not any proof that it can be effective."

Answered by AI

Is recruitment still happening for this medical trial?

"According to the information reported on clinicaltrials.gov, this trial is not currently seeking participants. The study was originally launched in March of 2023 and last updated January 11th 2023; however, there are an abundance of other medical trials now open for patient recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

2023. "Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05692635.

All > Brain Metastases