Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT05930418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Cardiovascular Magnetic Resonance Prognosticators In Pediatric Oncology Patients With Sepsis: A Priority Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction.
Primary Objectives:
(Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer.
CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness.
(Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer
Primary Objectives:
(Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer.
CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness.
(Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer
Detailed Description:
The primary purpose of this study is to evaluate the feasibility of obtaining cardiac MRI in pediatric patients with cancer post-septic shock which will be completed in an initial 5 patients to establish feasibility of successfully completing first study CMR within ten days of sepsis presentation without sedation.
This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for analysis of cardiovascular abnormalities and recovery in sepsis.
Feasibility Phase
The feasibility phase of the study will comprise the first 5 study participants. The aim of this stage is to establish feasibility of successfully completing the initial study CMR within ten days of sepsis presentation without sedation.
At completion of the feasibility phase, (first 5 participants) feasibility of data collection will be evaluated using the following stopping rule: If at least 4 of attempted 5 patient scans provide adequate available data for CMR analysis and can be completed without sedation or delay beyond the 10-day window (due to coordination or deferral due to hemodynamic instability), the study may continue to the completion phase. If fewer than 4 participants are able to complete the cardiac MRI, the study will be paused until any factors that can improve the feasibility may be identified. Data obtained during the feasibility phase will be included in analysis of CMR abnormalities.
Completion Phase
The Completion Phase will comprise approximately 20 participants in order to complete the pilot study to evaluate for abnormalities on CMR.
We estimate the feasibility phase will require up to 2 years to accrue and perform first CMR for the initial 5 patients and the completion phase will require an additional up to 18-24 months to accrue 15 additional patients who can complete CMR evaluation
This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for analysis of cardiovascular abnormalities and recovery in sepsis.
Feasibility Phase
The feasibility phase of the study will comprise the first 5 study participants. The aim of this stage is to establish feasibility of successfully completing the initial study CMR within ten days of sepsis presentation without sedation.
At completion of the feasibility phase, (first 5 participants) feasibility of data collection will be evaluated using the following stopping rule: If at least 4 of attempted 5 patient scans provide adequate available data for CMR analysis and can be completed without sedation or delay beyond the 10-day window (due to coordination or deferral due to hemodynamic instability), the study may continue to the completion phase. If fewer than 4 participants are able to complete the cardiac MRI, the study will be paused until any factors that can improve the feasibility may be identified. Data obtained during the feasibility phase will be included in analysis of CMR abnormalities.
Completion Phase
The Completion Phase will comprise approximately 20 participants in order to complete the pilot study to evaluate for abnormalities on CMR.
We estimate the feasibility phase will require up to 2 years to accrue and perform first CMR for the initial 5 patients and the completion phase will require an additional up to 18-24 months to accrue 15 additional patients who can complete CMR evaluation
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-04528 | OTHER | NCI Clinical Trial Registration Program | View |