Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06247449

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-18

100

Participants Needed

1

Research Sites

235 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

P

Princess Margaret Hospital, Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosis of Triple Negative or HER2 positive breast cancer according to 2018 ASCO/CAP guidelines
  • Stage IIb or III breast cancer
  • Patients with previous or other cancers that do not interfere with study safety or results may participate
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Creatinine clearance less than 30 mL/min as measured by the Cockcroft-Gault equation
  • Pregnant women are not allowed to participate due to unknown safety of IV contrast
  • Patients with central nervous system symptoms suggesting brain metastases needing brain imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sunnybrook Health Science Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

Loading map...

Research Team

K

Katarzyna Jerzak, MD, M.Sc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer | DecenTrialz