Testing Brain imaging with Analysis of circulating tumor DNA for breast cancer
Official title: MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
Interventions
Brain imaging
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
Analysis of circulating tumor DNA
Blood draw for analysis of circulating tumor DNA
Testing Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.
Canadian Sites (1)
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age \> 18.
- +Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
- +Stage IIb or III disease.
- +Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
- +Ability to understand and the willingness to sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document.
Exclusion
- −Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
- −Creatinine clearance \<30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
- −Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to detect a condition before symptoms appear.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Brain imaging, Analysis of circulating tumor DNA, Testing Morbidities Index.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: 18 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Asymptomatic brain metastasis frequency among HER2+ patients — measured over 18 months.
Asymptomatic brain metastasis frequency among Triple Negative patients — measured over 18 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06247449 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Brain imagingDiagnostic test
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
About Analysis of circulating tumor DNADiagnostic test
Blood draw for analysis of circulating tumor DNA
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
About Testing Morbidities IndexBehavioural
Questionnaire regarding the participant's perception of brain imaging.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 18 months.
The study as a whole is currently expected to finish around 2028-06-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. What proportion of patients with stage IIb or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (MRI) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis? 3. What clinical as well as liquid and tissue-based biomarkers are associated with asymptomatic detection of brain metastasis? Participants will undergo brain imaging, provide one blood sample (for analysis of ctDNA), and complete the Testing Morbidities Index (TMI) questionnaire after imaging is done. Procedures may take place either prior to or after completion of (neo)-adjuvant systemic therapy; however, the study interventions must take place within 18 months of initial breast cancer diagnosis.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.