MRI Screening for Brain Metastases in Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sunnybrook Health Sciences Centre
Disqualifiers: Low creatinine clearance, Pregnancy, CNS symptoms
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:
1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain?
2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis?
3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis?
Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for MRI Screening for Brain Metastases in Breast Cancer?
Research suggests that analyzing circulating tumor DNA (ctDNA) can help in predicting the effectiveness of treatments and monitoring cancer recurrence, which may be beneficial in managing breast cancer over time. Additionally, ctDNA has been used as a biomarker for patient selection and has shown potential in diagnosing severe forms of brain metastasis, indicating its usefulness in the context of brain imaging and cancer management.
12345Is MRI screening for brain metastases in breast cancer safe?
The research on circulating tumor DNA (ctDNA) and its use in brain metastases, including breast cancer, suggests that it is a noninvasive method and generally safe for monitoring tumor genetics. However, specific safety data for MRI screening in this context is not detailed in the available studies.
34678How does MRI screening for brain metastases in breast cancer differ from other treatments?
MRI screening for brain metastases in breast cancer is unique because it is the most sensitive method for detecting small, hidden lesions that might not be visible with other imaging techniques like CT scans. This makes it particularly valuable for early detection and precise assessment, which is crucial for planning treatments like surgery or radiosurgery.
910111213Eligibility Criteria
This trial is for people with stage II or III Triple Negative or HER2 positive breast cancer who haven't shown symptoms of brain metastasis. Participants must be within one year of their initial diagnosis and can join before or after systemic therapy.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent document
My breast cancer is either Triple Negative or HER2 positive.
I have another cancer, but it won't affect this treatment's safety or results.
+2 more
Exclusion Criteria
My kidney function is low, with a creatinine clearance under 30 mL/min.
I have symptoms that may suggest my cancer has spread to my brain.
Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Imaging and Biomarker Analysis
Participants undergo brain imaging and collect a blood sample for ctDNA analysis, followed by filling the Testing Morbidities Index (TMI)
1 day
1 visit (in-person)
Follow-up
Participants are monitored for the development of brain metastasis and undergo annual chart reviews
36 months
Annual chart reviews
Participant Groups
The study aims to find out how common asymptomatic brain metastases are in certain breast cancer patients by using MRI (or CT scans if MRI isn't possible), analyzing blood samples for tumor DNA, and assessing feelings about the screening process.
1Treatment groups
Experimental Treatment
Group I: Screening MRIExperimental Treatment3 Interventions
One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sunnybrook Health Science CentreToronto, Canada
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Who Is Running the Clinical Trial?
Sunnybrook Health Sciences CentreLead Sponsor
Trillium Health PartnersCollaborator
MOUNT SINAI HOSPITALCollaborator
Princess Margaret Hospital, CanadaCollaborator
References
Analysis of Circulating Tumor DNA to Predict Neoadjuvant Therapy Effectiveness and Breast Cancer Recurrence. [2023]Real-time detection and intervention can be used as potential measures to markedly decrease breast cancer mortality. Assessment of circulating tumor DNA (ctDNA) may offer great benefits for the management of breast cancer over time. However, the use of ctDNA to predict the effectiveness of neoadjuvant treatment and recurrence of breast cancer has rarely been studied.
Circulating tumor DNA in breast cancer: a biomarker for patient selection. [2023]This review aims to explore the role of circulating tumor DNA (ctDNA) as a biomarker for patient selection in breast cancer. We describe the current evidence and the main ongoing trials both in the early and metastatic setting.
Evaluating the cerebrospinal fluid ctDNA detection by next-generation sequencing in the diagnosis of meningeal Carcinomatosis. [2020]Meningeal carcinomatosis (MC) is the most severe form of brain metastasis and causes significant morbidity and mortality. Currently, the diagnosis of MC is routinely confirmed on the basis of clinical manifestation, positive cerebrospinal fluid (CSF) cytology, and/or neuroimaging features. However, negative rate of CSF cytology and neuroimaging findings often result in a failure to diagnose MC from the patients who actually have the disease. Here we evaluate the CSF circulating tumor DNA (ctDNA) in the diagnosis of MC.
Liquid biopsy prediction of axillary lymph node metastasis, cancer recurrence, and patient survival in breast cancer: A meta-analysis. [2022]Liquid biopsies using circulating tumor DNA (ctDNA) and cell-free DNA (cfDNA) have been developed for early cancer detection and patient monitoring. To investigate the clinical usefulness of ctDNA aberrations and cfDNA levels in patients with breast cancer (BC), we conducted a meta-analysis of 69 published studies on 5736 patients with BC.
Longitudinal Relationship between Idylla Plasma ctBRAF V600 Mutation Detection and Tumor Burden in Patients with Metastatic Melanoma. [2022]Circulating tumor DNA (ctDNA) may complement radiography for interim assessment of patients with cancer.
Circulating Tumor DNA in Adults With Glioma: A Systematic Review and Meta-Analysis of Biomarker Performance. [2022]Circulating tumor DNA (ctDNA) has emerged as a promising noninvasive biomarker to capture tumor genetics in patients with brain tumors. Research into its clinical utility, however, has not been standardized because the sensitivity and specificity of ctDNA remain undefined.
Genotyping tumour DNA in cerebrospinal fluid and plasma of a HER2-positive breast cancer patient with brain metastases. [2021]Central nervous system (CNS) involvement contributes to significant morbidity and mortality in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) and represents a major challenge for clinicians. Liquid biopsy of cerebrospinal fluid (CSF)-derived circulating tumour DNA (ctDNA) harbours clinically relevant genomic alterations in patients with CNS metastases and could be effective in tracking tumour evolution.
[Clinical Value of Cerebrospinal Fluid ctDNA in Patients with Non-small Cell Lung Cancer Meningeal Metastasis]. [2021]The mortality rate of lung cancer meningeal metastasis is extremely high. Circulating tumor DNA (ctDNA) has been confirmed to be contain the genomic alterations present in tumors and has been used to monitor tumor progression and response to treatments. Due to the presence of blood-brain barrier and other factors, peripheral blood ctDNA cannot reflect the information of brain lesions for patients with meningeal metastases. However, cerebrospinal fluid ctDNA as a test sample can better reflect the genetic status of intracranial tumors and guide clinical targeted treatment of intracranial lesions. This study explored the feasibility of cerebrospinal fluid ctNDA for evaluating non-small cell lung cancer (NSCLC) meningeal metastasis and the potential clinical value of cerebrospinal fluid ctDNA detection in NSCLC meningeal metastasis.
[Brain metastasis of breast cancer; imaging evaluation]. [2012]CNS involvement in breast cancer modifies the prognosis and the treatment of the disease. Imaging plays a leading role for the diagnosis, the pretherapeutic assessment and the follow-up. MRI is the most sensitive modality for the detection of infraclinic lesions, reported in about 15% of metastatic breast cancers. In addition to conventional MR study, diffusion MR, perfusion MR and spectroscopy have a diagnostic value with specificity of more than 95%; 3D study is required if neurosurgical resection or stereotactic radiosurgery is contemplated. The use of new drugs in clinical trials needs a precise and accurate follow up to assess their usefulness; appreciation of the response is based on the precise measure of the number of targets and of their size; The WHO and recently the RECIST have established the guidelines for measurement of the tumoral targets and to assess the response to treatments. Brain modifications related to surgery or stereotactic radiosurgery are well studied by MRI.
Time-delayed contrast-enhanced MRI improves detection of brain metastases and apparent treatment volumes. [2016]Contrast-enhanced MRI is the preeminent diagnostic test for brain metastasis (BM). Detection of BMs for stereotactic radiosurgery (SRS) planning may improve with a time delay following administration of a high-relaxivity agent for 1.5-T and 3-T imaging systems. Metastasis detection with time-delayed MRI was evaluated in this study.
Imaging of brain metastases. Comparison of computerized tomography (CT) and magnetic resonance imaging (MRI). [2019]For the demonstration of brain metastases both CT and MRI are available as diagnostic modalities. To compare both imaging methods as to their sensitivity in detecting brain metastases CT scans and MR images of 60 patients with suspected brain metastases were evaluated. Comparing contrast-enhanced CT and plain MRI neither modality was found to be clearly superior in this respect.
The Utility of Whole Body Imaging in the Evaluation of Solitary Brain Tumors. [2020]Solitary brain tumors can propose a diagnostic dilemma owing to the difficulty in differentiating between primary brain tumors and metastatic disease. The similar radiologic appearance on routine magnetic resonance imaging will necessitate the need for additional noninvasive testing. We sought to determine the clinical utility of preoperative whole body screening with computed tomography (CT) to detect metastatic disease in patients with solitary brain tumors.
[How can metastatic extension be assessed in the brain?]. [2006]MRI is the technique of choice to detect cerebral metastases. Double-dose delayed CT is the optimal CT examination to be performed in case of limited access to MRI. If the examination shows the presence of multiple metastases, MRI is not necessary. If CT shows an apparently single lesion, an MRI examination is essential, considering the number of lesions detected by MRI and not seen with CT.