Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Neoplasm Metastasis

Brain Neoplasms

Breast Diseases

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)

Brain Magnetic resonance (or computed tomography if magnetic resonance is contraindicated)

Brain imaging

One single blood draw for analysis of circulating tumor DNA

Analysis of circulating tumor DNA

Questionnaire regarding the participant's perception of brain imaging.

Testing Morbidities Index

Katarzyna Jerzak, MD, M.Sc

Katarzyna Jerzak, MD M.Sc

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.

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

Correlation between initial clinical and pathological staging with the rate of asymptomatic brain metastasis as seen in the brain MRI Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of asymptomatic brain metastasis as seen in the brain MRI

Correlation between initial clinical and pathological staging with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.

Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.

Proportion of eligible patients with Stage II or III HER2+ breast cancer who have asymptomatic brain metastasis

Proportion of eligible patients with Stage II or III Triple Negative breast cancer who have asymptomatic brain metastasis

Proportion of patients who are approached about the study who agree to enroll

Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)

Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer	NCT06247449	Breast Cancer	Brain imaging Analysis of cir... Testing Morbidi...	18 Years -	Sunnybrook Health Sciences Centre
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer	NCT06247449	Breast Cancer	Brain imaging Analysis of cir... Testing Morbidi...	18 Years -	Sunnybrook Health Sciences Centre

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