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MRI for Breast Cancer Diagnosis

N/A

Recruiting

Led By Bruce Lewis Daniel

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female with documented breast physical examination

Palpable or mammographically-detected suspect breast lesions

Must not have

Unable to complete the MR examination due to contraindications such as pacemakers, metallic implants, severe claustrophobia, aneurysm clips, pregnancy, current lactation, or other conditions precluding proximity to a strong magnetic field

Received an enhanced MR procedure within 48 hours, iodinated contrast within six hours, or known sensitivity to MR contrast agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if MRI is a better way to diagnose breast cancer than existing methods.

Who is the study for?

This trial is for women with suspicious breast lesions, either felt by touch or seen in mammograms within the last 3 months. It's also open to those who've had a lumpectomy and now have new abnormalities. Men, pregnant or breastfeeding women, individuals with certain metal implants, severe claustrophobia, or allergies to MRI contrast agents cannot participate.

What is being tested?

The study is testing how well magnetic resonance imaging (MRI) can identify and define breast cancer compared to established diagnostic methods like mammography.

What are the potential side effects?

While MRIs don't typically cause side effects as they don't use radiation like X-rays do, some may experience discomfort from lying still during the scan or anxiety due to the enclosed space of the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who has had a breast exam documented.

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I have a lump in my breast or an abnormal mammogram.

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I had a lumpectomy for breast cancer and now have suspicious changes needing a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an MRI due to a pacemaker, metal in my body, severe fear of tight spaces, pregnancy, breastfeeding, or similar reasons.

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I've had an MRI with contrast or am allergic to MRI dye.

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I am biologically male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Magnetic Resonance Imaging (MRI) of Breast CancerExperimental Treatment1 Intervention

Contrast-enhanced magnetic resonance imaging (MRI) using the standard department of Radiology MRI screening procedures. The duration of scanning may be variable, but will not exceed 90 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

0 / 6Eligibility criteria met