NCT04030507 Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
| NCT ID | NCT04030507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2019-07-26 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2019-07-26 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Ayal Aizer, MD, MHS
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT04030507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04030507 currently recruiting?
Yes, NCT04030507 is actively recruiting participants. Contact the research team at aaaizer@partners.org for enrollment information.
Where is the NCT04030507 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04030507 clinical trial?
NCT04030507 is sponsored by Brigham and Women's Hospital. The principal investigator is Ayal Aizer, MD, MHS at Brigham and Women's Hospital. The trial plans to enroll 214 participants.
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