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Cardiac 3D MRI in Pediatric Cancer Patients

2016年11月10日 更新者:Majd Makhoul

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.

研究概览

地位

撤销

条件

详细说明

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.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky Medical Center
      • Lexington、Kentucky、美国、40536
        • UK Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 26年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
childhood cancer survivors
Cardiac 3D MRI

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ventricular Function Measurement
大体时间:Up to 2 years
Quantify ventricular functional measurements including strain patterns and measurements using offline processing software that Dr. Fornwalt lab has.
Up to 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Majd Makhoul, MD、University of Kentucky

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2014年5月1日

首先提交符合 QC 标准的

2014年5月5日

首次发布 (估计)

2014年5月6日

研究记录更新

最后更新发布 (估计)

2016年11月15日

上次提交的符合 QC 标准的更新

2016年11月10日

最后验证

2016年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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