Evaluating heart health in pediatric cancer patients with sepsis using cardiac MRI
Cardiovascular Magnetic Resonance Prognosticators In Pediatric Oncology Patients With Sepsis: A Priority Pilot Study
NA · St. Jude Children's Research Hospital · NCT05930418
This study is testing if heart scans can be done safely on young cancer patients who have had severe infections to see if they have any heart problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 9 Years to 25 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital (other) |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05930418 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of conducting cardiac MRI in pediatric oncology patients who have experienced septic shock. The initial phase will involve five participants to determine if cardiac MRI can be performed within ten days of sepsis presentation without sedation. If successful, the study will proceed to analyze the frequency of cardiac abnormalities associated with subacute sepsis in this population. The findings will help guide heart failure management decisions for these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 9 to 25 currently receiving cancer treatment and diagnosed with sepsis.
Not a fit: Patients with pre-existing significant left ventricular dysfunction or those unable to meet MRI safety criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart failure management in pediatric cancer patients recovering from sepsis.
How similar studies have performed: While the approach of using cardiac MRI in this specific context is novel, similar studies have shown promise in assessing cardiac function in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 9 and 25 years of age at time of study enrollment * Currently receiving care for cancer at St. Jude * Diagnosed with sepsis according to Phoenix score Exclusion Criteria: * Participant has been diagnosed with clinically significant left ventricular dysfunction (EF \< 55%) prior to the onset of sepsis * 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 * Estimated glomerular filtration rate \< 45 ml/minute/1.73m2 * Does not meet MRI safety screening criteria.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Anthony Merlocco, MD — St. Jude Children's Research Hospital
- Study coordinator: Anthony Merlocco, MD
- Email: amerlocc@uthsc.edu
- Phone: 866-870-5570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Respiratory Distress Syndrome, Sepsis, Cardiovascular Shock