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临床试验/NCT01906021
NCT01906021已完成不适用

Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations

National Institutes of Health Clinical Center (CC)2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method

研究概览

简要总结

Background:

  • Ablation is a procedure that heats tumor tissue to a high temperature to destroy it. Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the site. Currently, doctors tell what area is heated by using the probe s manufacturer estimates. These estimates are imprecise. Doctors insert small needles to measure the temperature around the area being heated. Doctors also perform scans of the area, but these cannot show which tissue has been heated and which has not. Right now, only contrast scans can show that. But researchers have developed software that uses images from routine scans to create a temperature map. They want to test the software to see if doctors can monitor the procedure without using more needles and without contrast scans.

Objectives:

  • To test software that might help doctors perform ablations better in the future.

Eligibility:

  • People over 18 years of age already scheduled to have an ablation.

Design:

  • Participants will be screened with a medical history.
  • Participants will visit the clinic for their already-scheduled ablation. The doctor will use the study software to

analyze the temperature in the area being heated. The software will not come into contact with a participant s body.

  • Participants will undergo scans that are necessary for the procedure, but one or two additional scans may be done as part of this study.

详细描述

Background:

  • Lack of reliable non-invasive method to monitor ablation zone during radiofrequency or microwave ablation
  • Development of a non-invasive technique to examine temperature changes based on changes in CT or CBCT attenuation

Objectives:

-To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method.

Eligibility:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method

时间窗: two years

Bayesian median estimate will be used.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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