Trial details
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
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Trial short name: INSIGHT
Official title: MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
Principal Investigator: Dr. Katarzyna Jerzak
Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase: Other
Intervention: Diagnostic Test: Brain imaging Diagnostic, Test: Analysis of circulating tumor DNA, Behavioral: Testing Morbidities Index
Registration #:
NCT06247449 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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:
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?
How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis?
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.
Inclusion Criteria: 1. Age > 18. 2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines). 3. Stage II or III disease. 4. 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. 5. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast. 2. Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population. 3. Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
