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Diagnostic Test

MRI screening for Breast Cancer (SYMPToM Trial)

N/A
Waitlist Available
Led By Katarzya J Jerzak, MD MSc FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-, 8- and 12-months.
Awards & highlights

SYMPToM Trial Summary

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.

Eligible Conditions
  • Breast Cancer
  • Brain Tumor

SYMPToM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-, 8- and 12-months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-, 8- and 12-months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
Secondary outcome measures
Cancer-related anxiety (NCI PRO-CTCAE for anxiety).
Incidence of symptomatic brain metastases.
Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool).
+6 more
Other outcome measures
Proportion of patients with changes in CEST imaging that are suggestive of brain metastases prior to confirmation on contrast-enhanced MRI imaging.

SYMPToM Trial Design

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).

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,387 Total Patients Enrolled
30 Trials studying Breast Cancer
16,896 Patients Enrolled for Breast Cancer
Harvard UniversityOTHER
229 Previous Clinical Trials
474,455 Total Patients Enrolled
Katarzya J Jerzak, MD MSc FRCPCPrincipal InvestigatorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients With Triple Negative or HER2+ MBC
Dr. Katarzyna Jerzak 2018. "MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients With Triple Negative or HER2+ MBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03881605.
All > Brain Metastases
~8 spots leftby Apr 2025
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