Cardiac 3D MRI in Pediatric Cancer Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 8 - 26 |
| Updated: | 4/2/2016 |
| Start Date: | May 2015 |
| End Date: | May 2016 |
| Contact: | Majd Makhoul, MD |
| Email: | majd.makhoul@uky.edu |
| Phone: | (859) 218-2252 |
Left Ventricular Strain Assessment Using 3d Cardiac Magnetic Resonance Technique In Asymptomatic Pediatric Patients Who Received Cardiotoxic Chemotherapy
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.
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.
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials