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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04030507
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI — DEVICE
    MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).

Study Details

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).

Key Dates

Start date
Jul 26, 2019
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Inflammatory Breast Cancer Managed with Curative Intent
    * Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain * If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression.
  • Experimental: HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
    * An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry
  • No Intervention: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
    No initial MRI screening will be conducted
  • Experimental: Triple Negative Breast Cancer
    * An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry

Primary Outcome Measure

Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ayal Aizer
[email protected]
617-732-7560
Ayal Aizer, MD, MHS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MA

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