60 Participants Needed

MRI Surveillance for Brain Metastases from Lung Cancer

Recruiting at 1 trial location
SC
SN
Overseen ByStudy Nurse
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is MRI of the brain safe for humans?

MRI of the brain is generally considered safe for humans, as it is a non-invasive imaging technique that does not use ionizing radiation. The studies reviewed did not report any safety concerns related to the use of MRI for brain imaging in patients with lung cancer.12345

How does MRI surveillance for brain metastases from lung cancer differ from other treatments?

MRI surveillance is unique because it can detect brain metastases earlier than CT scans, as shown in studies where MRI identified metastases weeks before CT. This early detection can influence treatment decisions and improve patient outcomes by addressing metastases sooner.12567

What data supports the effectiveness of the treatment MRI for brain metastases from lung cancer?

MRI can detect brain metastases from lung cancer earlier than CT scans, as shown in a case where MRI identified brain metastases six weeks before they were visible on a CT scan.12458

Who Is on the Research Team?

Michael Farris, MD | Wake Forest ...

Michael K. Farris

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer is identified as adeno-squamous or mainly squamous.
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.
See 3 more

Exclusion Criteria

I am not pregnant and have taken a test to confirm this within the last 14 days.
You have been diagnosed with brain metastases through an MRI scan.
Patients who are pregnant or breastfeeding
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive curative intent radiation therapy

Varies

Surveillance MRI

Participants undergo scheduled brain MRI to monitor for brain metastases

14 months
Regular MRI visits as scheduled

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 months

What Are the Treatments Tested in This Trial?

Interventions

  • MRI of the Brain
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Surveillance MRI of the BrainExperimental Treatment4 Interventions

MRI of the Brain is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Magnetic Resonance Imaging of the Brain for:
🇺🇸
Approved in United States as Brain MRI for:
🇨🇦
Approved in Canada as Head MRI for:
🇯🇵
Approved in Japan as Cranial MRI for:
🇨🇳
Approved in China as Magnetic Resonance Imaging of the Brain for:
🇨🇭
Approved in Switzerland as MRI of the Head for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Magnetic resonance imaging (MRI) was able to detect two foci of brain metastasis from lung cancer six weeks earlier than computed tomography (CT), highlighting MRI's superior sensitivity in identifying brain lesions.
This case emphasizes the importance of using MRI for early detection of brain metastases in patients with metastatic lung cancer, potentially allowing for timely intervention.
Sensitivity of MRI in metastatic neoplasia: a case report.Pomeranz, SJ., Soila, K., Tobias, J., et al.[2019]
In a study of 1,382 patients with suspected early-stage non-small-cell lung cancer (NSCLC), 3.6% were found to have brain metastasis (BM), with tumor size being the only significant predictor of BM risk.
The median overall survival for patients with BM was 5.5 years, suggesting that selective brain MRI screening could be beneficial for high-risk patients, given the favorable outcomes associated with BM in this cohort.
Clinical features and molecular genetics associated with brain metastasis in suspected early-stage non-small cell lung cancer.Kim, K., Lee, J., Lee, JY., et al.[2023]
In a study of 628 asymptomatic patients with clinical stage IA non-small cell lung cancer (NSCLC), performing brain MRI for staging did not show any survival benefits, as there were no significant differences in brain metastasis-free survival, time to brain metastasis, or overall survival between those who had the MRI and those who did not.
The results remained consistent even after adjusting for confounding factors using methods like propensity score matching, indicating that routine brain MRI may not be necessary for staging in these patients.
No Prognostic Impact of Staging Brain MRI in Patients with Stage IA Non-Small Cell Lung Cancer.Nam, JG., Hong, H., Choi, SH., et al.[2022]

Citations

Sensitivity of MRI in metastatic neoplasia: a case report. [2019]
Clinical features and molecular genetics associated with brain metastasis in suspected early-stage non-small cell lung cancer. [2023]
No Prognostic Impact of Staging Brain MRI in Patients with Stage IA Non-Small Cell Lung Cancer. [2022]
Imaging of brain metastases of bronchial carcinomas with 7 T MRI - initial results. [2016]
Necessity of preoperative screening for brain metastasis in non-small cell lung cancer patients without lymph node metastasis. [2005]
Screening of brain metastasis with limited magnetic resonance imaging (MRI): clinical implications of using limited brain MRI during initial staging for non-small cell lung cancer patients. [2022]
[Silent brain metastasis in the initial staging of lung cancer: evaluation by computed tomography and magnetic resonance imaging]. [2019]
Cerebral imaging in the asymptomatic preoperative bronchogenic carcinoma patient: is it worthwhile? [2019]
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