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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04262830
Other study ID # 181758
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date September 30, 2029

Study information

Verified date April 2021
Source University of California, San Diego
Contact Hari Narayan, MD
Phone 8589665855
Email hnarayan@rchsd.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.


Description:

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies. Cardiac remodeling, function, and tissue characteristics will be examined using cardiac MRI data in combination with standard cardiac assessments (by echocardiography, electrocardiograms, and cardiac MRI) to assess the cardiotoxic effects of cancer therapy. Analyses will be performed in a cohort of adolescents and young adults with a history of childhood cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2029
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 39 Years
Eligibility Inclusion Criteria: - English and Spanish speaking male and female subjects, ages 13-39 years old - Diagnosis of cancer at age <22 years - Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior. Exclusion Criteria: - Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants. - Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia. - Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus). - Patients with orthodontic braces or metallic implants in the thorax or abdomen/lumbar spine, even if MRI-compatible, will be excluded as these may cause artifacts and limit image quality. - Pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiac magnetic resonance imaging (MRI)
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
Echocardiography
Echocardiography, heart ultrasound, will be performed in conjunction with cardiac MRI.
Electrocardiogram
Measuring conduction abnormalities

Locations

Country Name City State
United States Rady Children's Hospital San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Hari Narayan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left ventricular ejection fraction (LVEF) LVEF is an assessment of left ventricular global systolic function. 5 years
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