MRI Screening for Brain Metastases in Breast Cancer
(SYMPToM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKatarzya J Jerzak, MD MSc FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if symptoms of brain metastases develop). Patients will complete questionnaires about quality of life and cancer-related anxiety throughout the study. To determine why some cancers spread to the brain and others do not, blood samples will be collected to analyze the genetic makeup of patients' breast cancers. Finally, a novel MRI imaging technique that detects abnormal metabolism in the brain will be used to help detect brain metastases even earlier than the standard MRI. If results are promising, we will conduct a large multi-centre randomized trial to determine whether screening for brain metastases can help them live longer with improved quality of life.

Eligibility Criteria

This trial is for women over 18 with HER2+ or triple negative metastatic breast cancer, diagnosed within the last 12 weeks and without symptoms or known brain metastases. It's not open to those with other cancers that could affect the study results.

Inclusion Criteria

I am 18 years old or older.

My breast cancer is either triple negative or HER2 positive.

My cancer spread to other parts was diagnosed within the last 3 months.

+4 more

Participant Groups

The study compares routine MRI screening every four months against MRIs only when symptoms appear, in detecting brain metastases early. Participants will also provide blood samples and complete questionnaires on life quality and anxiety.

2Treatment groups

Experimental Treatment

Active Control

Group I: MRI screeningExperimental Treatment1 Intervention

Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.

Group II: Symptom-directed surveillanceActive Control1 Intervention

Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability).