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MRI Screening for Brain Metastases in Breast Cancer

N/A
Recruiting
Led By Ayal Aizer, MD, MHS
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be age 18 years or older.
Be older than 18 years old
Must not have
Patients with a prior diagnosis of brain metastases
Participants who have chronic kidney disease stage IV-V or end stage renal disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is testing if MRI can find brain metastases in people with breast cancer.

Who is the study for?
This trial is for adults over 18 with confirmed breast cancer, either starting first/second-line chemo for metastatic disease or managing inflammatory breast cancer. They must expect to live more than 12 weeks and agree to use birth control. It's not for those with MRI contraindications, severe kidney disease, gadolinium allergies, or existing brain metastases.
What is being tested?
The study tests if MRI can effectively screen for the spread of breast cancer to the brain in patients undergoing certain treatments. The goal is to assess how useful MRI scans are in detecting these brain metastases early on.
What are the potential side effects?
MRI itself typically doesn't cause side effects; however, some may experience discomfort from lying still during the scan or claustrophobia. There's also a small risk of an allergic reaction to gadolinium contrast used during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with brain metastases before.
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I have advanced or end-stage kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Brain Metastases
Incidence of Symptomatic Brain Metastases
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Triple Negative Breast CancerExperimental Treatment1 Intervention
* 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
Group II: Inflammatory Breast Cancer Managed with Curative IntentExperimental Treatment1 Intervention
* 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.
Group III: HR+ or HER2+ Metastatic Breast Cancer - Screening ArmExperimental Treatment1 Intervention
* 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
Group IV: HR+ or HER2+ Metastatic Breast Cancer - No Screening ArmActive Control1 Intervention
No initial MRI screening will be conducted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1620

Find a Location

Who is running the clinical trial?

Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,711 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
352,883 Total Patients Enrolled
144 Trials studying Breast Cancer
21,798 Patients Enrolled for Breast Cancer
Ayal Aizer, MD, MHSPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute
Yale University School Of Medicine (Medical School)
1 Previous Clinical Trials
134 Total Patients Enrolled
1 Trials studying Breast Cancer
134 Patients Enrolled for Breast Cancer

Media Library

MRI Clinical Trial Eligibility Overview. Trial Name: NCT04030507 — N/A
Breast Cancer Research Study Groups: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm, Inflammatory Breast Cancer Managed with Curative Intent, HR+ or HER2+ Metastatic Breast Cancer - Screening Arm, Triple Negative Breast Cancer
Breast Cancer Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT04030507 — N/A
MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04030507 — N/A
~13 spots leftby Feb 2025
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