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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

All-cause mortality

Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain

Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain

+13 more

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

~1370

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Conquer Cancer FoundationOTHER

19 Previous Clinical Trials

3,761 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,766 Total Patients Enrolled

141 Trials studying Breast Cancer

22,403 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this experiment?

"Correct. Data from clinicaltrials.gov attests to this medical study's active recruitment process, which commenced on July 26th 2019 and was recently updated on 19th of July 2022. 214 patients are needed at one site for the trial's completion."

Answered by AI

How many volunteers are contributing to this experiment?

"Indeed, the records on clinicaltrials.gov demonstrate that this trial is actively enrolling participants. Its first posting was made on July 26th 2019 and it has been updated as recently as July 19th 2022. A total of 214 patients will be accepted at one set location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ayal Aizer, MD 2019. "Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04030507.

All > Inflammatory Breast Cancer