MRI for Breast Cancer Diagnosis

Overseen By Jocelyn Steffan

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Male, Pacemakers, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if magnetic resonance imaging (MRI) surpasses other imaging methods in finding and defining breast cancer. Researchers will use contrast-enhanced MRI to assess its effectiveness in detecting breast abnormalities. Women with noticeable lumps, suspicious mammogram results, or new suspicious changes after breast cancer surgery might be suitable candidates. The trial includes a single MRI session lasting up to 90 minutes, adhering to standard safety guidelines. Participants should not have metal implants, severe claustrophobia, or have undergone recent similar procedures. As an unphased trial, this study allows participants to contribute to advancing breast cancer detection methods.

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 prior data suggests that MRI is safe for breast cancer diagnosis?

Research has shown that MRI (Magnetic Resonance Imaging) safely checks for breast cancer. MRI is noninvasive, meaning it doesn't involve surgery or entering the body, and it avoids radiation, unlike some other imaging tests. This generally makes it easy for patients to handle.

Studies have found that MRI effectively detects breast cancer, with about a 95% success rate. However, false positives can occur, where the test indicates cancer when there isn't any. This may lead to further tests, such as ultrasounds or biopsies, for confirmation.

Overall, MRI is considered a safe option with minimal risks. The main concern is that unclear MRI results might necessitate additional tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI for breast cancer diagnosis because it offers a non-invasive way to detect cancer that could be more precise than traditional methods like mammograms or ultrasounds. Unlike these standard imaging techniques, MRI uses magnetic fields and radio waves to produce detailed images of breast tissue, which can highlight abnormalities more clearly. This approach can potentially improve early detection and reduce false positives, leading to better outcomes for patients.

What evidence suggests that MRI is effective for breast cancer diagnosis?

Research has shown that MRI (magnetic resonance imaging) effectively detects breast cancer. Studies indicate that MRI identifies cancer in 95 out of 100 cases, outperforming mammograms and ultrasounds. For women at high risk, such as those with BRCA gene mutations, MRI excels at early detection. Although MRI is less effective at ruling out cancer in those without it, its primary advantage lies in identifying cancers that other methods might miss. Overall, MRI serves as a powerful diagnostic tool for breast cancer, especially in higher-risk individuals. Participants in this trial will undergo contrast-enhanced MRI to assess its effectiveness in diagnosing breast cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Bruce L Daniel

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MRI

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 (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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38142230/

Outcomes of High-Risk Breast MRI Screening in Women ...

High-risk screening breast MRI was effective at detecting early breast cancer and associated with favorable outcomes.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8178936/

Magnetic Resonance Imaging in Screening of Breast Cancer

The average sensitivity of MR imaging is around 95%, compared with 40% for mammography and 45% for ultrasonography based on prospective trial data, with MR ...

3.

breastsurgeons.org

breastsurgeons.org/docs/statements/Consensus-Guideline-on-Diagnostic-and-Screening-Magnetic-Resonance-Imaging-of-the-Breast.pdf

Diagnostic and Screening Magnetic Resonance Imaging of ...

In studies comparing the effectiveness of breast MRI to mammography for screening of high- risk women for breast cancer - including patients with BRCA mutations ...

4.

insightsimaging.springeropen.com

insightsimaging.springeropen.com/articles/10.1186/s13244-024-01653-4

The paradox of MRI for breast cancer screening: high-risk and ...

Sensitivity was significantly higher for MRI (96%) than for DBT (39%). Specificity was significantly higher for DBT (97%) than for MRI (87%).

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa031759

Efficacy of MRI and Mammography for Breast-Cancer ...

A total of 32 cancers were confirmed among 452 MRI screenings with such findings, for a positive predictive value of 7.1 percent (Table 3). With a cutoff level ...

6.

mayoclinic.org

mayoclinic.org/tests-procedures/breast-mri/about/pac-20384809

Breast MRI

Risks · False-positive results. A breast MRI might show a need for more testing. More testing, such as a breast ultrasound or breast biopsy, ...

7.

uspreventiveservicestaskforce.org

uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening

Recommendation: Breast Cancer: Screening

In that trial, the rate of recall among participants who underwent additional imaging with MRI was 94.9 per 1000 screens, the false-positive ...

8.

radiologyinfo.org

radiologyinfo.org/en/info/breastmr

Breast MRI

MRI is a noninvasive imaging technique that does not involve exposure to radiation. MRI has proven valuable in detecting and staging breast cancer, particularly ...