Using MRI to screen for brain metastases in breast cancer patients
Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study
This study is testing if using MRI scans can help find brain metastases earlier in breast cancer patients with different types of the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04030507 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of magnetic resonance imaging (MRI) in detecting brain metastases in patients with various subtypes of breast cancer. The study includes four cohorts: patients with triple negative breast cancer undergoing MRI screening, patients with hormone receptor positive and HER2 positive breast cancer randomized to receive either MRI screening or no screening, and patients with inflammatory breast cancer receiving MRI screening. The goal is to determine if routine MRI screening can be integrated into standard care to improve early detection of brain metastases. This Phase II trial aims to provide insights into the safety and utility of MRI in this context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed breast cancer and evidence of distant metastases or inflammatory breast cancer being treated with curative intent.
Not a fit: Patients without breast cancer or those who do not have evidence of metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of brain metastases in breast cancer patients, potentially improving treatment outcomes.
How similar studies have performed: Other studies have explored MRI screening in cancer patients, but this specific approach for breast cancer brain metastases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ayal Aizer, MD, MHS — Brigham and Women's Hospital
- Study coordinator: Ayal Aizer, MD, MHS
- Email: aaaizer@partners.org
- Phone: 617-732-7560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.