Cardiac 3D MRI in Pediatric Cancer Patients
- Conditions
- Childhood Cancer
- Interventions
- Procedure: Cardiac 3D MRI
- Registration Number
- NCT02130934
- Lead Sponsor
- Majd Makhoul
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Ongoing cancer treatment
- Pregnancy
- Inability to undergo a cardiac MRI
- Abnormal ventricular systolic or diastolic function on echocardiogram
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description childhood cancer survivors Cardiac 3D MRI Cardiac 3D MRI
- Primary Outcome Measures
Name Time Method Ventricular Function Measurement Up to 2 years Quantify ventricular functional measurements including strain patterns and measurements using offline processing software that Dr. Fornwalt lab has.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UK Medical Center
🇺🇸Lexington, Kentucky, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States