RecruitingNot ApplicableNCT06247449

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

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

100 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether routine MRI brain scans (using a contrast agent called gadolinium) should be offered to people with triple-negative or HER2-positive breast cancer at stage IIb or III, who are otherwise considered lower risk for brain metastases. The aim is to detect brain metastases earlier, before symptoms appear, when they might be more treatable. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with triple-negative OR HER2-positive breast cancer - Your cancer is stage IIb or stage III - You are able to understand and consent to participating - A prior or current separate cancer is acceptable if it does not interfere with the study **You may NOT be eligible if...** - Your kidney function is too low for the MRI contrast agent (creatinine clearance below 30 mL/min) - You are pregnant - You already have neurological symptoms that suggest brain involvement - You are allergic to MRI contrast agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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