Clinical trial NCT03038997: Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
Official title: Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Cardiotoxicity
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previous exposure to anthracyclines between the ages of 8-25 years of age.

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.

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)
* 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

Primary outcomes:
measure: Echocardiogram marker measurements pre ABC chemo and post ABC
timeFrame: At the end of each cardiac MRI exam through study completion, up to 5 years
Secondary outcomes:
measure: Detection of cardiac toxicity on MRI and echocardiogram
timeFrame: At the end of each cardiac MRI exam through study completion, up to 5 years
measure: Serum biomarkers correlation
timeFrame: At the end of the study, up to 10 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National
name: Niti Dham, MD
role: PRINCIPAL_INVESTIGATOR
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