MRI for Breast Cancer Diagnosis

Recruiting in Palo Alto (17 mi)

Overseen by Bruce L Daniel

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Male, Pacemakers, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MRI for breast cancer diagnosis?

MRI is effective in providing detailed images of breast lesions, which helps in planning breast-conservation therapy and surgical management. It is particularly useful for women with dense breast tissue or those with discrepancies between mammography and ultrasound, leading to more accurate treatment decisions. ^{1 2 3 4 5}

Is MRI safe for humans?

MRI (Magnetic Resonance Imaging) is generally considered safe for humans, but there are some concerns about false-positive results, which can lead to unnecessary stress and additional testing. Additionally, artifacts (distortions in the images) can occur, which may affect the accuracy of the diagnosis. ^{6 7 8 9 10}

How does MRI differ from other treatments for breast cancer?

MRI for breast cancer is unique because it provides detailed images that help in diagnosing and planning treatment, especially in cases where other imaging methods are less effective, such as in dense breast tissue or when multiple tumors are present. It is not a treatment itself but a tool that aids in better surgical planning and assessing the effectiveness of treatments like chemotherapy. ^{1 6 8 11 12}

Research Team

Bruce L Daniel

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

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

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

You need to have had a mammogram within the last 3 months before the MR studies.

Exclusion Criteria

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

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

I am biologically male.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo contrast-enhanced magnetic resonance imaging (MRI) using standard department of Radiology MRI screening procedures

Up to 90 minutes

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• MRI (Procedure)

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

Participant Groups

Group I: Magnetic Resonance Imaging (MRI) of Breast Cancer Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

Breast MRI is a highly effective tool for diagnosing breast cancer, particularly in women with dense breast tissue or those with silicone implants, as it provides detailed images that help assess the extent of the disease.

The use of breast MRI can enhance surgical planning and management by accurately characterizing tumor size and location, which is crucial for optimizing treatments like lumpectomy and evaluating the effectiveness of chemotherapy and radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI in breast cancer diagnosis and treatment. Harms, SE.[2019]

In a study of 45 breast cancer patients and 35 benign tumor patients, key MRI indicators for diagnosing breast cancer were identified, including tumor edge features, time-signal intensity curve (TIC) types, and apparent diffusion coefficient (ADC) values at b=500 s/mm2.

The combination of conventional MRI, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced MRI provided the best diagnostic approach, with magnetic resonance spectroscopy (MRS) serving as a useful supplementary tool for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. Jiang, Z., Wang, Y., He, Z., et al.[2015]

Magnetic resonance imaging (MRI) has emerged as the most accurate noninvasive method for local staging of breast cancer, significantly improving the measurement of tumor size and detection of multicentric disease.

The enhanced accuracy of MRI in evaluating breast tumors can influence treatment selection and prognosis, potentially transforming how clinical trials for new cancer therapies are designed and assessed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in breast cancer staging. Davis, PL., McCarty, KS.[2019]

In a study of 493 breast cancer patients, MRI provided additional clinical information in 52.9% of cases, leading to changes in management for 44.3% of patients, with 83.9% of those changes deemed appropriate.

While MRI can enhance clinical decision-making, it often results in more extensive surgeries (40% of cases) without demonstrating a clear prognostic benefit, suggesting it should be used selectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of magnetic resonance imaging in managing selected women with newly diagnosed breast cancer. Scomersi, S., Urbani, M., Tonutti, M., et al.[2010]

Magnetic resonance imaging (MR) is becoming increasingly important in the management and research of breast cancer, offering new opportunities to enhance patient care and understanding of the disease's biology.

The review highlights both the potential benefits of MR in clinical settings and the limitations, indicating that while MR can improve care in certain areas, it may also lead to unnecessary procedures in others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for primary breast cancer management: current role and new applications. Esserman, L., Wolverton, D., Hylton, N.[2019]

Breast MRI is particularly beneficial for high-risk patients, those with a new breast cancer diagnosis, and for monitoring treatment responses, showing high sensitivity for earlier and more accurate cancer detection.

Despite its advantages, breast MRI has limitations such as high costs and modest specificity, which can lead to false positives, highlighting the need for careful application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. DeMartini, W., Lehman, C., Partridge, S.[2008]

In a study of 320 high-risk women who underwent 757 breast MRI procedures from 2007 to 2013, the number of false-positive findings (harms) decreased with each subsequent MRI, indicating improved screening efficiency over time.

Despite the initial higher rate of false positives, breast MRI continued to successfully detect cancer, with a total of 6 malignancies identified from 75 biopsy procedures, demonstrating its ongoing utility as a screening tool for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. Pederson, HJ., O'Rourke, C., Lyons, J., et al.[2015]

A retrospective analysis of 494 MRI-guided breast biopsies from 440 patients over 16 years showed that 73% of the biopsies were benign and 27% were malignant, indicating a consistent distribution of diagnoses during this period.

There was a significant increase in the detection of benign papillary and sclerosing lesions, rising from 13% to 31% between the earlier (2004-2011) and later (2012-2019) years, suggesting a shift in the types of benign conditions identified through MRI-guided biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sixteen-Year Institutional Review of Magnetic Resonance Imaging-Guided Breast Biopsies: Trends in Histologic Diagnoses With Radiologic Correlation. Motanagh, SA., Dwan, D., Azizgolshani, N., et al.[2023]

In a study of 630 breast MRI examinations, artefacts were present in 33% of cases, primarily due to patient movement (48.6%) and issues with fat saturation (33.6%), which could potentially affect image interpretation.

Despite the presence of artefacts, none impacted the diagnostic interpretation of the images, highlighting the importance of a skilled team to identify and correct these issues to ensure accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast MRI artefacts: evaluation and solutions in 630 consecutive patients. Fiaschetti, V., Pistolese, CA., Funel, V., et al.[2015]

In a study of 2524 MRI examinations from 1794 patients, significant unilateral artifacts were found in 29.2% of cases and bilateral artifacts in 37.8%, indicating a notable prevalence of image quality issues that could affect breast cancer diagnosis.

The analysis revealed that older age and higher magnetic field strength were positively associated with the presence of MRI artifacts, while a higher body mass index was negatively associated, suggesting these factors could be targeted to improve image quality in MRI protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and influencing factors for artifact development in breast MRI-derived maximum intensity projections. Kapsner, LA., Balbach, EL., Laun, FB., et al.[2023]

Breast MRI is increasingly recognized as a valuable tool in managing known or suspected breast cancers, particularly for resolving unclear findings from mammograms and staging cancer when multiple or bilateral disease is suspected.

Ongoing research is exploring the use of breast MRI for high-risk patients, assessing dense breast tissue, and evaluating responses to chemotherapy, highlighting its potential to enhance breast cancer management beyond conventional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI in the detection and management of breast cancer. Padhani, AR., Ah-See, ML., Makris, A.[2007]

MRI is highly sensitive for detecting breast cancer, often identifying small tumors that mammography or ultrasound may miss, making it a valuable tool for surgical planning.

Despite its high sensitivity, MRI has modest specificity, which raises questions about its role compared to other imaging methods and highlights the need for clear guidelines on its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of breast cancer: clinical indications and breast MRI reporting system. Ikeda, DM., Baker, DR., Daniel, BL.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

MRI in breast cancer diagnosis and treatment. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in breast cancer staging. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Role of magnetic resonance imaging in managing selected women with newly diagnosed breast cancer. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for primary breast cancer management: current role and new applications. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Sixteen-Year Institutional Review of Magnetic Resonance Imaging-Guided Breast Biopsies: Trends in Histologic Diagnoses With Radiologic Correlation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Breast MRI artefacts: evaluation and solutions in 630 consecutive patients. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence and influencing factors for artifact development in breast MRI-derived maximum intensity projections. [2023]

11. England pubmed.ncbi.nlm.nih.gov

MRI in the detection and management of breast cancer. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of breast cancer: clinical indications and breast MRI reporting system. [2019]