Status:
RECRUITING
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Conquer Cancer Foundation
Conditions:
Breast Cancer
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.
- Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.
- Participants must be age 18 years or older.
- Participants must have a life expectancy of greater than 12 weeks.
- Participants must be willing to undergo study procedures.
- The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- Participants must possess the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
- Participants who have chronic kidney disease stage IV-V or end stage renal disease.
- Participants with a history of anaphylactic reactions to gadolinium.
- Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
- Patients with a prior diagnosis of brain metastases
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04030507
Start Date
July 26 2019
End Date
February 1 2026
Last Update
October 23 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115