Cardiac MRI for Heart Issues After Sepsis in Pediatric Cancer Patients

Overseen By Joshua Wolf, MBBS. PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Left ventricular dysfunction, Pregnancy, Renal dysfunction, 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: 20

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand heart issues that may occur in children with cancer after severe sepsis, using a special heart scan called a cardiac MRI (Cardiac Magnetic Resonance Imaging). Researchers seek to determine the frequency of these heart problems and improve their management. The trial targets children and young adults undergoing cancer treatment who have recently experienced severe sepsis. As an unphased trial, it offers participants a unique opportunity to contribute to important research that could enhance heart health management for young cancer patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this protocol is safe for pediatric cancer patients?

Research has shown that cardiac MRI safely assesses heart health. It effectively detects heart issues early, especially in childhood cancer survivors. Unlike some other imaging tests, cardiac MRI does not use radiation, enhancing its safety.

While detailed information on side effects is limited, patients usually tolerate cardiac MRI well. Researchers commonly use it in heart disease studies to identify early signs of heart problems in at-risk patients, such as children with cancer. Overall, cardiac MRI reliably and safely examines the heart's structure and function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cardiac MRI for heart issues after sepsis in pediatric cancer patients because it offers a non-invasive way to get detailed images of the heart. Unlike standard methods that may rely on more invasive procedures or less detailed imaging, Cardiac MRI provides comprehensive insights into heart function and structure without exposing patients to radiation. This approach could lead to better understanding and management of heart issues in these vulnerable patients, potentially improving their long-term health outcomes.

What evidence suggests that this protocol is effective for identifying heart issues after sepsis in pediatric cancer patients?

Research has shown that cardiac MRI (magnetic resonance imaging) is a valuable tool for assessing heart health in cancer patients. Studies have found that it can detect heart problems early, especially after severe infections like sepsis. In this trial, participants will undergo cardiac MRI to evaluate heart health following sepsis. Cardiac MRI excels at identifying inflammation and other heart issues that might not be visible with other methods. In children with cancer, it helps doctors understand if and how sepsis has impacted the heart. This information can guide crucial decisions about heart care and treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Anthony Merlocco, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for pediatric cancer patients at St. Jude, aged 9-25, who have recently suffered from severe sepsis. They must be stable enough post-sepsis to undergo a cardiac MRI without anesthesia and not have significant heart dysfunction or conditions that make MRI unsafe.

Inclusion Criteria

You have been diagnosed with severe sepsis based on specific medical guidelines.

I am between 9 and 25 years old.

Currently receiving care for cancer at St. Jude

Exclusion Criteria

I was diagnosed with a weak heart (EF < 55%) before getting a severe infection.

My kidney function is reduced, with an eGFR below 45.

Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Participant is pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Evaluate the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer

Up to 2 years

Initial CMR within 10 days of sepsis presentation

Completion Phase

Evaluate for abnormalities on CMR in approximately 20 participants

18-24 months

CMR evaluation within 10 days of sepsis presentation

Follow-up

Participants are monitored for cardiac abnormalities and recovery post-CMR

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac MRI

Trial Overview The study tests the use of cardiac MRI to detect heart issues in children with cancer after sepsis. It checks if MRIs can be done safely soon after sepsis and how often these scans show heart inflammation or dysfunction within 10 days of a severe sepsis episode.

How Is the Trial Designed?

Group I: Cardiac MRI after sepsis Experimental Treatment 1 Intervention

Participants who meet the eligibility criteria of severe sepsis.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

Automated segmentation of left ventricular parameters in pediatric cardiac MRI was successful in 93.3% of cases, indicating its feasibility for assessing heart function in children, particularly those with suspected myocarditis.

Manual adjustments to the automated segmentation improved the accuracy of certain measurements, such as ejection fraction and myocardial mass, providing clinically acceptable results for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric cardiac MRI: automated left-ventricular volumes and function analysis and effects of manual adjustments. Hammon, M., Janka, R., Dankerl, P., et al.[2018]

Cardiac magnetic resonance (CMR) imaging has become essential in evaluating pediatric heart disease, providing detailed insights that enhance the assessment of both congenital and acquired conditions.

CMR can often replace invasive procedures like angiographic catheterization, making it a safer option for patients, while also complementing traditional echocardiography for more comprehensive cardiac evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in pediatric cardiovascular magnetic resonance imaging. Ntsinjana, HN., Tann, O., Taylor, AM.[2022]

Patients undergoing potentially cardiotoxic cancer treatments are at risk for various heart issues, including reduced left ventricular mass and impaired heart function.

Cardiovascular magnetic resonance imaging is a valuable tool for evaluating heart structure and function in these patients, aiding in the diagnosis and management of heart disease related to cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in the Oncology Patient. Jordan, JH., Todd, RM., Vasu, S., et al.[2023]

Cardiac MRI is safe for critically ill infants with congenital heart disease, showing low risk and minimal hemodynamic changes during the procedure, as evidenced by a study of 20 patients in the pediatric cardiac intensive care unit.

The imaging provided crucial information that led to surgical or catheter interventions in 70% of the cases, highlighting its clinical utility in guiding management decisions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? Sarikouch, S., Schaeffler, R., Körperich, H., 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]

Cardiac magnetic resonance (CMR) imaging is highly accurate and reproducible, making it a valuable tool for diagnosing and screening for cardiotoxicity and other cardiac diseases in cancer patients.

CMR's ability to detect subtle changes in heart function and tissue composition enhances our understanding of cardiotoxicity, highlighting its growing importance in both clinical practice and research within cardio-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular MRI in Cardio-Oncology. Bottinor, W., Trankle, CR., Hundley, WG.[2022]

Cardiac MRI is increasingly recognized for its role in evaluating heart problems in cancer patients, helping to identify cardiac abnormalities and dysfunction related to cancer treatments.

Current guidelines now recommend the use of cardiac MRI as a noninvasive tool in cancer management, highlighting its importance in both diagnosing and managing cardiovascular complications associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI in cardio-oncology: A review of cardiac complications in oncologic care. Jeong, D., Gladish, G., Chitiboi, T., et al.[2020]

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]

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]

Cancer therapies can lead to both short-term and long-term cardiovascular issues, making it crucial to identify patients at risk for cardiotoxicity early on.

Cardiovascular magnetic resonance (MR) imaging is a promising tool in cardio-oncology, offering a comprehensive evaluation of cardiac structures beyond just assessing left-ventricular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular MR imaging in cardio-oncology. Tamene, AM., Masri, C., Konety, SH.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6242266/

Cardiovascular Magnetic Resonance in the Oncology Patient In this report, we review the use of CMR for assessing the heart and surrounding structures in patients with or surviving cancer suspected of having cardiac ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001308

Cardiovascular Toxicity in Patients Treated for Childhood ... This document, focused on current data in pediatric patients and survivors of pediatric cancer, builds on the prior American Heart Association scientific ...

3. jcmr-online.biomedcentral.com jcmr-online.biomedcentral.com/articles/10.1186/s12968-022-00873-1

SCMR expert consensus statement for cardiovascular ... This article provides guidelines for the performance and reporting of CMR in the pediatric population for non-structural (“non-congenital”) heart disease.

4. stjude.org stjude.org/care-treatment/clinical-trials/crimson2-cardiac-mri-predictors-for-sepsis-in-cancer.html

CRIMSON2: Cardiac MRI Predictors for Sepsis in Cancer A clinical trial to study the use of cardiac magnetic resonance for sepsis in children with cancer. Learn more.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023071402

MR imaging of primary benign cardiac tumors in the ... CMR has had an increased role in the diagnostic pathway of pediatric cardiac masses, due to its high accuracy in characterizing mass tissue properties.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40488773/

Cardiac magnetic resonance imaging in the assessment of ... The aim of this document is to provide guidance in the utility, acquisition, and interpretation of cardiac MRI in childhood cancer survivors.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40948714/

Cardiac magnetic resonance imaging assessment of ... This review focuses on the role of CMR in myocardial tissue characterization, particularly its ability to detect and quantify fibrosis using ...