Evaluation of PET/MRI in Children With Cancer
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:
- You will schedule your PET/CT examination with the MGH radiology department according to the orders and instructions of your oncologist (cancer doctor)
- Study personnel will coordinate the scheduling of your PET/MRI examination to coincide with date and time of your PET/CT examination
- 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
- The PET/MRI will take up to 60 minutes to complete and after it is completed you will be free to go
- 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.
- 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
- The study will last for 12 months, after which time you will no longer be enrolled
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Michael Gee, MD, PhD
- 电话号码:6177244207
- 邮箱:msgee@partners.org
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital
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接触:
- Michael Gee, MD, PhD
- 电话号码:617-724-4207
- 邮箱:msgee@partners.org
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首席研究员:
- Michael Gee, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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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
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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
调查人员
- 首席研究员:Michael Gee, MD, PhD、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
PET-MRI的临床试验
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Assistance Publique - Hôpitaux de Paris招聘中
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Turku University HospitalGE Healthcare; Blue Earth Diagnostics完全的
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Norwegian University of Science and TechnologyUniversity Hospital of North Norway; Haukeland University Hospital; St. Olavs Hospital招聘中
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)主动,不招人
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Gustave Roussy, Cancer Campus, Grand Paris未知
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Marco PicardiFederico II University未知