Cardiac 3D MRI in Pediatric Cancer Patients

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02130934
• Other study ID #: 14-0315
• Status: Withdrawn
• Phase: N/A
• First received: May 1, 2014
• Last updated: November 10, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 26 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Procedure:
• Cardiac 3D MRI

Locations

Country	Name	City	State
United States	UK Medical Center	Lexington	Kentucky
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Majd Makhoul

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No