Cardiac MRI for Breast Cancer

(UPBEAT Trial)

Recruiting at 65 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Chemotherapy, Estrogen antagonists

Disqualifiers: Heart disease, Hypertension, Diabetes, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 24 months

403 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients receiving chemotherapy and/or estrogen antagonist aromatase inhibitors, it seems likely that you can continue with these treatments.

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

While the research does not directly address Cardiac MRI for breast cancer, MRI in general has shown high sensitivity in detecting breast cancer and can provide additional clinical information that may change management plans. MRI has been effective in detecting multicentric disease and monitoring tumor response to chemotherapy, which suggests its potential usefulness in comprehensive cancer care. ^{1 2 3 4 5}

Is Cardiac MRI safe for humans?

Cardiac MRI is generally considered safe and does not involve exposure to ionizing radiation. However, there can be rare adverse events, especially when using gadolinium-based contrast agents, as seen in a study involving 72,839 patients. ^{6 7 8 9 10}

How does the treatment using cardiac MRI differ from other treatments for breast cancer?

Cardiac MRI for breast cancer is unique because it uses magnetic resonance imaging to provide detailed images of the heart and surrounding tissues, which can help in the detection and management of breast cancer. Unlike traditional treatments, this approach focuses on imaging to assess the extent of the disease and monitor response to therapy, offering a non-invasive way to gather critical information about the cancer. ^{11 12 13 14 15}

What is the purpose of this trial?

This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.

Research Team

Gregory Hundley, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for women over 18 with Stage I-III breast cancer, who can hold their breath for 10 seconds, walk two blocks without severe symptoms, and exercise on a treadmill or cycle. They should be scheduled to receive certain chemotherapies or estrogen blockers but not have heart issues, uncontrolled hypertension, recent clots or attacks, metal implants incompatible with MRI, or severe pulmonary conditions.

Inclusion Criteria

I am over 18 years old.

I have early to locally advanced breast cancer, not spread far, and am seeking a cure.

I am scheduled for chemotherapy or hormone therapy for my cancer.

Exclusion Criteria

Pregnant women and women who are breast-feeding

In the past month, I haven't had major heart issues or trouble understanding English.

Your heart's pumping ability is less than 50%.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including MRI measures of CV function, exercise capacity, fatigue, and biomarkers are collected

1-2 weeks

1 visit (in-person)

Treatment

Breast cancer patients receive chemotherapy, and measurements are repeated at 3, 12, and 24 months

24 months

Multiple visits (in-person) at 3, 12, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 12, and 24 months

24 months

3 visits (in-person) at 3, 12, and 24 months

Treatment Details

Interventions

• Cardiac MRI

Trial Overview The study aims to understand if chemotherapy for breast cancer impacts heart health compared to those without cancer. It involves using Cardiac MRI to monitor the heart's condition during treatment and assess any changes in exercise capacity and fatigue levels.

Participant Groups

Group I: Non-Cancer Controls Experimental Treatment 1 Intervention

Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.

Group II: Breast Cancer Patients Experimental Treatment 1 Intervention

Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

Cardiac MRI is a powerful tool for diagnosing and managing cardiovascular issues in cancer patients, effectively distinguishing between benign and malignant cardiac tumors and assessing the impact of cancer treatments on heart health.

The technique can detect both early and long-term cardiotoxic effects of cancer therapies using advanced imaging sequences, making it essential for integrated cancer care and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Magnetic Resonance Imaging in Oncology. Jeong, D., Patel, A., Francois, CJ., et al.[2018]

The EuroCMR Registry aims to evaluate the clinical utility of cardiovascular magnetic resonance (CMR) imaging, focusing on image quality, safety, and its impact on patient management across multiple European centers.

This registry will also track patients with suspected coronary artery disease and hypertrophic cardiomyopathy over 12 months to gather important prognostic data, enhancing our understanding of CMR's effectiveness in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. Wagner, A., Bruder, O., Schneider, S., et al.[2021]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

Sensitivity of enhanced MRI for the detection of breast cancer: new, multicentric, residual, and recurrent. [2020]

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

Magnetic resonance imaging of the breast. [2017]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Preoperative magnetic resonance imaging in breast cancer: meta-analysis of surgical outcomes. [2022]

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

The Role of Cardiac Magnetic Resonance Imaging to Detect Cardiac Toxicity From Cancer Therapeutics. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

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

Cardiac Magnetic Resonance Imaging in Oncology. [2018]

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

Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]

11. India pubmed.ncbi.nlm.nih.gov

The utility of MRI for the screening and staging of breast cancer. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

[Breast magnetic resonance imaging: state of the art and clinical applications]. [2016]

13. England pubmed.ncbi.nlm.nih.gov

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

14. 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]

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

Evolving Role of MRI in Breast Cancer Imaging. [2016]