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Cardiac 3D MRI in Pediatric Cancer Patients

NCT ID: NCT02130934

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Cancer

Keywords

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Childhood cancer anthracyclines cardiotoxicity cardiac MRI cumulative does of at least 150 mg/m2 of anthracyclines Ventricular function

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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childhood cancer survivors

Cardiac 3D MRI

Cardiac 3D MRI

Intervention Type PROCEDURE

Interventions

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Cardiac 3D MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Majd Makhoul

OTHER

Sponsor Role lead

Responsible Party

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Majd Makhoul

Sponsor/Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Majd Makhoul, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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UK Medical Center

Lexington, Kentucky, United States

Site Status

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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14-0315

Identifier Type: -

Identifier Source: org_study_id