MRI Surveillance for Brain Metastases from Lung Cancer

Recruiting at 1 trial location

Overseen By Study Nurse

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Known brain metastases, Pregnant, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 5 7 8}

Research Team

Michael K. Farris

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Surveillance MRI of the Brain Experimental Treatment 4 Interventions

Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.

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:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions

Approved in United States as Brain MRI for:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions
• Monitoring of stroke and transient ischemic attack

Approved in Canada as Head MRI for:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions

Approved in Japan as Cranial MRI for:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions

Approved in China as Magnetic Resonance Imaging of the Brain for:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions

Approved in Switzerland as MRI of the Head for:

• Diagnosis and monitoring of brain diseases and disorders
• Detection of brain tumors
• Evaluation of neurological conditions

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 12 patients with brain metastases from bronchial carcinomas, 7 T MRI with susceptibility-weighted imaging (SWI) detected 20% more intracranial microhemorrhages compared to 1.5 T MRI, highlighting its superior spatial resolution.

While the 7 T MRI identified a similar number of brain metastases as the 1.5 T MRI, the enhanced imaging capabilities of the 7 T system may improve the overall assessment of brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of brain metastases of bronchial carcinomas with 7 T MRI - initial results. Mönninghoff, C., Maderwald, S., Theysohn, JM., et al.[2016]

In a study of 338 patients with non-small cell lung cancer (NSCLC), only 2.1% of those who underwent routine brain MRI were found to have asymptomatic brain metastasis, suggesting low prevalence.

The findings indicate that routine brain MRI may not be necessary for preoperative patients with resectable NSCLC, especially since no brain metastases were found in patients with N0 disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necessity of preoperative screening for brain metastasis in non-small cell lung cancer patients without lymph node metastasis. Yohena, T., Yoshino, I., Kitajima, M., et al.[2005]

In a study of 183 patients with non-small cell lung cancer (NSCLC), early screening for brain metastases (BM) using MRI revealed a significantly higher incidence of BM (20.8%) compared to a control group (4.6%) that only received MRI if they showed neurological symptoms.

While the MRI screening did not lead to a significant difference in overall survival between the groups, it did allow for timely treatment and improved quality of life, particularly for patients with BM alone, who had a longer survival time (49 weeks) compared to those with multiple systemic metastases (27 weeks).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kim, SY., Kim, JS., Park, HS., et al.[2022]

In a study of 169 lung cancer patients without neurological symptoms, silent brain metastases were found in 8.3% of cases, highlighting the importance of brain imaging during initial staging.

Cranial MRI was more effective than CT in detecting brain metastases, especially smaller ones and multiple metastases, suggesting it should be the preferred imaging method for lung cancer patients during staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Silent brain metastasis in the initial staging of lung cancer: evaluation by computed tomography and magnetic resonance imaging]. de Cos Escuín, JS., Menna, DM., González, MA., et al.[2019]

In a study of 42 patients with operable bronchogenic carcinoma, neither contrast MRI nor enhanced CT scans revealed any unsuspected cerebral metastatic lesions, suggesting that routine screening may not be necessary for asymptomatic patients.

Although MRI showed more subtle benign findings, the lack of detected metastatic disease in this low-risk group indicates that the costs of these imaging techniques may not be justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral imaging in the asymptomatic preoperative bronchogenic carcinoma patient: is it worthwhile? Cole, FH., Thomas, JE., Wilcox, AB., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Sensitivity of MRI in metastatic neoplasia: a case report. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical features and molecular genetics associated with brain metastasis in suspected early-stage non-small cell lung cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

No Prognostic Impact of Staging Brain MRI in Patients with Stage IA Non-Small Cell Lung Cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Imaging of brain metastases of bronchial carcinomas with 7 T MRI - initial results. [2016]

5. Japan pubmed.ncbi.nlm.nih.gov

Necessity of preoperative screening for brain metastasis in non-small cell lung cancer patients without lymph node metastasis. [2005]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

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]

7. Spain pubmed.ncbi.nlm.nih.gov

[Silent brain metastasis in the initial staging of lung cancer: evaluation by computed tomography and magnetic resonance imaging]. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Cerebral imaging in the asymptomatic preoperative bronchogenic carcinoma patient: is it worthwhile? [2019]