RECRUITING

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

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Conditions

Breast CancerHER2-positive Breast CancerTriple Negative Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastInflammatory Breast CancerMetastatic Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-07-26
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04030507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Participants must be age 18 years or older.
  4. * Participants must have a life expectancy of greater than 12 weeks.
  5. * Participants must be willing to undergo study procedures.
  6. * 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.
  7. * Participants must possess the ability to understand and the willingness to sign a written informed consent document.
  1. * Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
  2. * Participants who have chronic kidney disease stage IV-V or end stage renal disease.
  3. * Participants with a history of anaphylactic reactions to gadolinium.
  4. * 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.
  5. * Patients with a prior diagnosis of brain metastases

Contacts and Locations

Study Contact

Ayal Aizer, MD, MHS
CONTACT
617-732-7560
aaaizer@partners.org
Ivy Ricca, BA
CONTACT
6175828927
iricca@mgb.org

Principal Investigator

Ayal Aizer, MD, MHS
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Ayal Aizer, MD, MHS, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-26
Study Completion Date2026-02

Study Record Updates

Study Start Date2019-07-26
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • HER2-positive Breast Cancer
  • Triple Negative Breast Cancer
  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Inflammatory Breast Cancer
  • Metastatic breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer
  • HER2-positive Breast Cancer
  • Triple Negative Breast Cancer
  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Inflammatory Breast Cancer
  • Metastatic Breast Cancer