Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Launched by DANA-FARBER CANCER INSTITUTE · Jul 22, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how effective magnetic resonance imaging (MRI) is in finding breast cancer that has spread to the brain. The research focuses on various types of breast cancer, including HER2-positive and triple-negative breast cancers, among others. The goal is to see if using MRI can help detect brain metastases early, which is important for managing treatment and patient care.

To participate in this study, you need to be at least 18 years old and have been diagnosed with breast cancer that has spread to other parts of the body. You should also be starting a new round of chemotherapy soon. Participants must be willing to undergo MRI scans and agree to use contraception if they can become pregnant, as the effects of MRI contrast agents on unborn babies are not well understood. If you qualify and decide to join, you can expect to undergo a series of MRI scans as part of the study. Keep in mind that this trial cannot include individuals who have had brain metastases before or who have certain medical conditions that would make MRI unsafe.

Gender

ALL

Eligibility 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