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Slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| childhood cancer survivors | Cardiac 3D MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac 3D MRI | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular Function Measurement | Quantify ventricular functional measurements including strain patterns and measurements using offline processing software that Dr. Fornwalt lab has. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will come from the Kentucky Children's Hospital Hematology/Oncology clinic. The study team will ask the subject's primary physician to introduce the study in clinic to any patient who is identified by the study team as meeting the enrollment criteria. If the patient and his/her family are interested in participating, a member of the study team will be notified, and will then consent / assent the patient and family for the study. Patients who wish to consider the study and potentially enroll later will be given contact information to call the study personnel if they wish to enroll later.
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| Name | Affiliation | Role |
|---|---|---|
| Majd Makhoul, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Medical Center | Lexington | Kentucky | 40536 | United States | ||
| University of Kentucky Medical Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lexington |
| Kentucky |
| 40536 |
| United States |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |