Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Niti Dham
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Echocardiogram marker measurements pre ABC chemo and post ABC
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
Detailed Description
Cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy. Cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents. The ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population. The current standard testing uses echocardiography, which is not as sensitive as cardiac MRI or serum biomarkers.
Investigators
Niti Dham
MD
Children's National Research Institute
Eligibility Criteria
Inclusion Criteria
- •Subjects that have received anthracycline based chemotherapy
- •Age: 8 years old - 25 years old
- •Subjects that do not require sedation for cardiac MRI.
- •Subjects must have completed treatment in the last 10 years
Exclusion Criteria
- •Patients with significant congenital heart defects
- •Patients with renal injury or renal failure, defined as an estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73 m2 body surface area), as previously calculated)
- •Patients that require sedation for a cardiac MRI
- •Subjects that are pregnant or lactating
- •Patients with contraindications to a cardiac MRI:
- •Cardiac pacemaker or implantable defibrillator
- •Cerebral aneurysm clip
- •Neural stimulator
- •Metallic ocular foreign body
- •Any implanted device (i.e. insulin pump, drug infusion device)
Outcomes
Primary Outcomes
Echocardiogram marker measurements pre ABC chemo and post ABC
Time Frame: At the end of each cardiac MRI exam through study completion, up to 5 years
•Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.
Secondary Outcomes
- Detection of cardiac toxicity on MRI and echocardiogram(At the end of each cardiac MRI exam through study completion, up to 5 years)
- Serum biomarkers correlation(At the end of the study, up to 10 years)