Early Detection of Cardiac Toxicity in Childhood Cancer Survivors

Terminated

• Conditions: Heart Failure; Cardiotoxicity

• Registration Number: NCT03038997
• Lead Sponsor: Niti Dham

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2018-03-11
• Study Completion: 2018-03-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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)
• Claustrophobia
• Metal shrapnel or bullet
• Investigator assessment of inability to comply with protocol
• Unable/unwilling to lie still throughout the research procedure
• Persons with cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiogram marker measurements pre ABC chemo and post ABC	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 Outcome Measures

Name	Time	Method
Detection of cardiac toxicity on MRI and echocardiogram	At the end of each cardiac MRI exam through study completion, up to 5 years	•Measure sensitivity of detecting cardiac toxicity between standard echocardiogram, speckle tracking on echo, and MRI
Serum biomarkers correlation	At the end of the study, up to 10 years	•Correlate measurement of serum biomarkers with prevalence of cardiac changes measured on echocardiograms and MRI imaging.

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States