Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 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
- 否
入选标准
- •INCLUSION CRITERIA:
- •Subjects must be scheduled for a hepatic radiofrequency or microwave ablation in interventional radiology requiring thermocouples for temperature monitoring. Any patient undergoing a hepatic radiofrequency or microwave ablation could be eligible for this protocol.
- •Must be age 18 years or older.
排除标准
- •Subjects have an altered mental status precluding understanding or consenting to the procedure
- •Subjects have a body weight in excess of 375 lbs.
- •Subject is pregnant
研究组 & 干预措施
1
Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements
干预措施: Ablation Probe (Procedure)
1
Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements
干预措施: CT/CBCT thermometry method (Procedure)
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