Left Ventricular Strain Assessment Using 3d Cardiac Magnetic Resonance Technique In Asymptomatic Pediatric Patients Who Received Cardiotoxic Chemotherapy

Cardiac 3D MRI in Pediatric Cancer Patients

Sponsors

Lead sponsor: Majd Makhoul

Source University of Kentucky
Brief Summary

This is a non-randomized prospective pilot study in a single academic center with historic controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who have undergone childhood cancer treatment that has cardio-toxic effects to historic controls. The ultimate goal of this study is to develop a safe and effective method for early diagnosis of heart problems in children who are receiving chemotherapy treatments that may be toxic to the heart.

Detailed Description

The following tests and procedures will be performed after consent has been obtained. All tests and procedures noted below are being done for the sole purpose of the study:

Visit 1. Subjects will be asked to complete some questionnaires and answer questions regarding smoking status and use of alcohol or smokeless tobacco. We will also gather basic information such as age, height, weight, gender, ethnicity, race, pertinent medical history as well as collect vital sign information (height, weight, blood pressure, heart and respiratory rate.) Next, subjects will undergo a routine transthoracic echocardiogram.

Visit 2. Following the completion of the echocardiogram, and if selected to take part in the study, subjects will be schedule for a cardiac MRI test within a 3 months period.

When subjects come in for Visit 2, they will receive a 12 lead electrocardiograph (ECG) before the cardiac 3D MRI.

All females who are capable of becoming pregnant, except those who are age 11 and under, will then undergo urine pregnancy testing. If it is found that you are pregnant you will not be allowed to be in the study. If the female is under 18 and a positive pregnancy test result is obtained, we will inform both the participant and her parent/guardian.

Subjects may then be placed in a "simulated" MRI to teach them what it will be like to enter the scanner and also train them on how to breathe calmly and regularly during the scan.

Training will involve the use of a PrimeSense 3D sensor, similar to the cameras used in active videogame systems such as the Xbox Kinect, which will generate a 3D picture of their chest as they breathe. Following this training session, subjects will then undergo cardiac 3D MRI. Study participations will end after this visit.

Overall Status Withdrawn
Start Date May 2014
Completion Date March 2016
Primary Completion Date March 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Ventricular Function Measurement Up to 2 years
Condition
Intervention

Intervention type: Procedure

Intervention name: Cardiac 3D MRI

Arm group label: childhood cancer survivors

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Childhood cancer treatment which has been completed

- Received anthracyclines as part of childhood cancer treatment, at least 150 mg/m2 as cumulative dose

- normal left ventricular systolic and diastolic functions on echocardiogram

Exclusion Criteria:

- Ongoing cancer treatment

- Pregnancy

- Inability to undergo a cardiac MRI

- Abnormal ventricular systolic or diastolic function on echocardiogram

Gender: All

Minimum age: 8 Years

Maximum age: 26 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Majd Makhoul, MD Principal Investigator University of Kentucky
Location
facility
UK Medical Center | Lexington, Kentucky, 40536, United States
University of Kentucky Medical Center | Lexington, Kentucky, 40536, United States
Location Countries

United States

Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of Kentucky

Investigator full name: Majd Makhoul

Investigator title: Sponsor/Investigator

Keywords
Has Expanded Access No
Arm Group

Arm group label: childhood cancer survivors

Description: Cardiac 3D MRI

Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov