Cardiac MRI for Breast Cancer

(UPBEAT Trial)

Not currently recruiting at 67 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how chemotherapy for breast cancer affects the heart, exercise ability, and fatigue levels compared to those without cancer. Researchers use cardiac MRI (Cardiac Magnetic Resonance Imaging) scans to measure heart function, exercise capacity, and fatigue over time. Ideal participants are women with Stage I-III breast cancer who can walk two blocks without issues and are scheduled for chemotherapy. The trial also includes healthy women who have never had cancer or undergone related treatments for comparison.

As an unphased trial, this study allows participants to contribute to important research that could enhance future cancer care.

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 prior data suggests that Cardiac MRI is safe for assessing heart function in breast cancer patients?

Research has shown that Cardiac MRI, a type of heart scan, is generally safe and easy to manage. This scan helps assess heart health, especially for patients receiving chemotherapy for breast cancer. Studies have found that Cardiac MRI effectively detects any heart damage that cancer treatments might cause.

In one study, researchers found no major safety issues with using Cardiac MRI in breast cancer patients. The scan did not cause any serious side effects, making it a reliable method for monitoring heart health. Another study demonstrated that even when used to track heart changes over two years, the scan remained safe and did not cause any problems.

Overall, Cardiac MRI is considered a safe way to evaluate heart function in patients undergoing chemotherapy. It provides important information without adding health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cardiac MRI in breast cancer patients because it provides a non-invasive and detailed look at heart function, which is crucial for patients undergoing chemotherapy. Unlike traditional methods like echocardiograms, cardiac MRI offers more precise measurements of cardiac structures and function without exposing patients to radiation. This advanced imaging technique helps in early detection of heart issues that might arise from cancer treatments, allowing for timely interventions. By monitoring the heart health of breast cancer patients in such a detailed manner, researchers hope to improve overall treatment outcomes and quality of life.

What evidence suggests that Cardiac MRI is effective for assessing heart health in breast cancer patients receiving chemotherapy?

Research has shown that cardiac MRI effectively identifies heart problems caused by cancer treatments. In this trial, breast cancer patients receiving either non-anthracycline or anthracycline chemotherapy will undergo cardiac MRIs to monitor heart health. Studies have found that cardiac MRI can detect early signs of heart damage in patients receiving chemotherapy for breast cancer. Specifically, one study discovered frequent signs of early heart damage that do not yet cause symptoms after short-term cancer treatment. These findings suggest that cardiac MRI could be a useful tool for monitoring heart health in breast cancer patients undergoing chemotherapy, helping doctors catch potential heart issues before they become serious. ^{5 6 7 8 9}

Who Is on the Research Team?

Gregory Hundley, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

You can hold your breath for 10 seconds.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7268598/

Cardiotoxicity evaluation using magnetic resonance ... A 3-min cardiac imaging protocol will be added to the breast MRI examination to diagnose cardiotoxicity in breast cancer patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301621027322

Cardiac Magnetic Resonance Imaging and Blood ... Patients with breast cancer receive lower doses to smaller volumes of the heart compared with lymphoma patients, but with their excellent long-term survival, it ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573256/

Multimodal Imaging of Cancer Therapy-Related Cardiac ... This review focuses on multimodality imaging of cardiotoxicity in cancer patients, with the aim of evaluating the effectiveness of different techniques.

4. eurradiolexp.springeropen.com eurradiolexp.springeropen.com/articles/10.1186/s41747-023-00338-9

Longitudinal assessment of cardiac parameters through MRI ... Cardiac MRI scans showed frequent signs of subclinical cardiotoxicity after short-term anti-HER2 therapy and nonanthracycline-based chemotherapy.

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001174

Cardiovascular Imaging in Contemporary Cardio-Oncology Advances in cancer therapeutics have led to dramatic improvements in survival, now inclusive of nearly 20 million patients and rising.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10228774/

Quantitative cardiovascular magnetic resonance findings and ... CMR and CMR strain evaluation are important imaging tools to assess breast cancer patients for chemotherapy induced cardiotoxicity. Although ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7596658/

A Pilot Study of Cardiac MRI in Breast Cancer Survivors ... This is a pilot trial assessing cardiac damage using CMR in patients who received anthracycline-based chemotherapy and three-dimensional conformal radiotherapy ...

8. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/ryct.240231

The MEDIRAD EARLY-HEART Study A modest but persistent reduction in LV GLS over a 2-year follow-up period was associated with the cardiac radiation dose.

9. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2803933

Comprehensive Cardiovascular Magnetic Resonance ... In this cohort study including 136 women, serial CMR tissue characterization demonstrated peak myocardial inflammation and edema 3 months after trastuzumab ...