MRI Surveillance for Brain Metastases from Lung Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Known brain metastases, Pregnant, Breastfeeding, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
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.
12345Is 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.
12356How 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.
12578Eligibility 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.
+4 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
+1 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest Baptist Comprehensive Cancer CenteWinston-Salem, NC
Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Sensitivity of MRI in metastatic neoplasia: a case report. [2019]Serial magnetic resonance imaging (MRI) and computed tomography (CT) were performed on a patient with metastatic lung cancer to brain. Magnetic resonance (MR) visualized two foci of intracerebral metastasis six weeks prior to CT.
Clinical features and molecular genetics associated with brain metastasis in suspected early-stage non-small cell lung cancer. [2023]Regarding whether brain magnetic resonance imaging (MRI) should be routine in patients with suspected early-stage lung cancer, guideline recommendations are inconsistent. Therefore, we performed this study to evaluate the incidence of and risk factors for brain metastasis (BM) in patients with suspected early-stage non-small-cell lung cancer (NSCLC).
No Prognostic Impact of Staging Brain MRI in Patients with Stage IA Non-Small Cell Lung Cancer. [2022]Background Although various guidelines discourage performing brain MRI for staging purposes in asymptomatic patients with clinical stage IA non-small cell lung cancer (NSCLC), evidence regarding their postoperative survival is lacking. Purpose To investigate the survival benefit of performing brain MRI in asymptomatic patients with early-stage NSCLC. Materials and Methods Patients who underwent curative resection between February 2009 and March 2016 for clinical TNM stage T1N0M0 NSCLC were retrospectively included. Patient survival and development of brain metastasis during postoperative surveillance were documented. The cumulative survival rate and incidence of brain metastasis were compared between patients who underwent surgery with or without staging brain MRI by using Cox regression and a Fine-Gray subdistribution hazard model, respectively, for multivariable adjustment. Propensity score matching and inverse probability of treatment weighting were applied for confounder adjustment. Results A total of 628 patients (mean age, 64 years ± 10 [SD]; 319 men) were included, of whom 53% (331 of 628) underwent staging brain MRI. In the multivariable analyses, brain MRI did not show prognostic benefits for brain metastasis-free survival (hazard ratio [HR], 1.06; 95% CI: 0.69, 1.63; P = .79), time to brain metastasis (HR, 1.60; 95% CI: 0.70, 3.94; P = .29), and overall survival (HR, 0.86; 95% CI, 0.54, 1.37; P = .54). Consistent results were obtained after propensity score matching (brain metastasis-free survival [HR, 0.97; 95% CI: 0.60, 1.57; P = .91], time to brain metastasis [HR, 1.29; 95% CI: 0.50, 3.33; P = .60], and overall survival [HR, 0.89; 95% CI: 0.53, 1.51; P = .67]) and inverse probability of treatment weighting. Conclusion No difference was observed between asymptomatic patients with clinical stage IA non-small cell lung cancer who underwent staging brain MRI and those who did not in terms of brain metastasis-free survival, time to brain metastasis, and overall survival. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Bizzi and Pascuzzo in this issue.
Imaging of brain metastases of bronchial carcinomas with 7 T MRI - initial results. [2016]To compare the depiction of brain metastases of bronchial carcinomas on susceptibility-weighted and contrast-enhanced images with 7 T and at 1.5 T MRI.
Necessity of preoperative screening for brain metastasis in non-small cell lung cancer patients without lymph node metastasis. [2005]The exclusion of brain metastasis is important to determine the optimal treatment plan in patients with non-small cell lung cancer (NSCLC). However, a routine examination using magnetic resonance imaging (MRI) for the brain remains controversial in preoperative patients with resectable disease.
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]The purpose of this prospective study was to determine whether using magnetic resonance imaging (MRI) for early screening for brain metastases (BM) can improve quality of life, survival in patients with non-small cell lung cancer (NSCLC). The study group comprised 183 patients newly diagnosed with NSCLC. All patients underwent limited brain MRI and routine workups. The control group comprised 131 patients with NSCLC who underwent limited brain MRI only if they had neurologic symptoms. The incidence of BM was 20.8% (38/183) in the study group and 4.6% (6/131) in the control group. The rate of upstaging based on the MRI data was 13.5% (15/111) overall and 15.9% (11/69) in patients that had been considered initially to be resectable surgically. There was no significant difference in survival outcome between the groups. Patients who had BM alone had a greater overall survival time (49 weeks) than those who had multiple systemic metastases (27 weeks; p=0.0307). In conclusions, limited brain MRI appears to be a useful, cost-effective method to screen for BM at the time of initial staging. And it may facilitate timely treatment of patients with NSCLC and improve their survival and quality of life.
[Silent brain metastasis in the initial staging of lung cancer: evaluation by computed tomography and magnetic resonance imaging]. [2019]Brain metastases are common in patients with lung cancer and influence both prognosis and treatment decisions. The aim of this study was to evaluate the incidence of silent brain metastasis during the initial staging of lung cancer using cranial computed tomography (CT) and magnetic resonance imaging (MRI).
Cerebral imaging in the asymptomatic preoperative bronchogenic carcinoma patient: is it worthwhile? [2019]The issue of screening for cerebral metastatic disease in the preoperative bronchogenic carcinoma patient remains unsettled and changes with advancing technology. A prospective nonrandomized study was designed to compare contrast magnetic resonance imaging (MRI) with computed tomography (CT) after several clinical situations suggested improved sensitivity for the former study. Patients with clinically operable disease and normal neurologic examinations were referred for both enhanced cerebral CT and MRI studies. Forty-two patients were entered and completed the enhanced CT scan; only 30 tolerated the MRI. The demographic data and histology of the patients appeared fairly typical for a series of operative candidates. No unsuspected metastatic lesion was found in this selected and low-risk group. We conclude that neither MRI nor enhanced CT scan is indicated in the asymptomatic bronchogenic carcinoma patient due to expense and lack of positive findings. Magnetic resonance imaging demonstrated more subtle benign pathology, but this study did not allow comparison of the two techniques in detection of metastatic disease.