此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Evaluation of PET/MRI in Children With Cancer

2021年8月30日 更新者:Michael Gee、Massachusetts General Hospital
This research study is a Pilot study (a small preliminary study to assess the feasibility of a larger, more in depth study involving a new test or procedure) and is being done to evaluate the feasibility and accuracy of PET/MRI in the evaluation of cancer. PET/MRI is a FDA approved technology that is currently being studied to assess its accuracy and utility in the diagnosis and management of a variety of diseases and patient populations. The focus of this particular study will be to compare the performance of PET/MRI in its ability to detect and characterize cancerous tumors using positron emission topography and computed tomography (PET/CT) as a reference standard.

研究概览

详细说明

If you agree to participate in this study you will be asked to fill out a screening questionnaire to determine if you can participate. No additional screening tests or procedures will be necessary prior to your participation in this study.

If the screening questionnaire shows that you are eligible to participate in the research study, you will be scheduled to undergo your PET/MRI in conjunction with your PET/CT. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

After th screening procedures confirm that you are eligible to participate in the research study:

  1. You will schedule your PET/CT examination with the MGH radiology department according to the orders and instructions of your oncologist (cancer doctor)
  2. Study personnel will coordinate the scheduling of your PET/MRI examination to coincide with date and time of your PET/CT examination
  3. Following the performance of your PET/CT examination you will be transported (with your accompanying family member(s)) to the Charlestown Navy Yard MGH imaging facility where you will undergo your PET/MRI examination. No additional dose of radioactive tracer (a substance which is labeled with a radioactive molecule that can be tracked within your body based on the radiation it emits) will be given as part of your PET/MRI examination
  4. The PET/MRI will take up to 60 minutes to complete and after it is completed you will be free to go
  5. The PET/MRI images will be interpreted by physicians (trained radiologists) as part of the study analysis; however no report of the findings will be made available to you. You will have access to the results of the PET/CT examination as you would any other clinical imaging examination.
  6. If you are willing, with each subsequent PET/CT examination you undergo while enrolled in the study, you will also undergo a PET/MRI examination
  7. The study will last for 12 months, after which time you will no longer be enrolled

研究类型

介入性

注册 (预期的)

20

阶段

  • 不适用

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。

学习联系方式

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital
        • 接触:
        • 首席研究员:
          • Michael Gee, MD, PhD

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

5年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Able to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history

Exclusion Criteria:

  • Requirement for sedation or anesthesia of any kind in order to undergo MRI scanning
  • Electrical implants such as cardiac pacemakers or perfusion pumps
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
  • Pregnancy or breastfeeding
  • Pre-existing medical conditions or claustrophobic reactions, and any greater than normal potential for cardiac arrest

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

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Imaging
PET-MRI PET-CT
Imaging
Imaging

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
Comparison of Imaging Quality between PET-MRI and PET-CT
大体时间:2 years
To perform a qualitative comparison of image quality between PET-MRI and PET-CT exams being performed on pediatric oncology patients during the same visit
2 years

次要结果测量

结果测量
措施说明
大体时间
Comparison of PET-MRI SUV Values and PET-CT FDG Reference
大体时间:2 years
To compare the ability of PET-MRI to determine the extent of active malignancy by comparing PET-MRI SUV values with PET-CT FDG reference
2 years
Assessment of Unexpected Indeterminate Lesions
大体时间:2 years
To assess the number of unexpected indeterminate lesions detected on PET-MRI and PET-CT studies requiring additional workup
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。

调查人员

  • 首席研究员:Michael Gee, MD, PhD、Massachusetts General Hospital

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

2012年10月1日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2013年4月22日

首先提交符合 QC 标准的

2013年4月24日

首次发布 (估计)

2013年4月25日

研究记录更新

最后更新发布 (实际的)

2021年9月1日

上次提交的符合 QC 标准的更新

2021年8月30日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 12-307

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.

PET-MRI的临床试验

3
订阅