Trials / Active Not Recruiting
Active Not RecruitingNCT03881605
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
Routine MRI Screening Versus Symptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative and HER2+ Metastatic Breast Cancer (MBC): a Single-centre Randomized Pilot Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Please see trial details below.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MRI screening | A standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months. |
Timeline
- Start date
- 2018-11-08
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2019-03-19
- Last updated
- 2025-01-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03881605. Inclusion in this directory is not an endorsement.