Study of New Software Used During Ablations
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 12/21/2018 |
| Start Date: | July 19, 2013 |
| End Date: | August 5, 2015 |
Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations
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.
- 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.
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:
- Subjects are eligible if:
--They are scheduled in interventional radiology for hepatic radiofrequency or microwave
ablation requiring thermocouples for monitoring
- Subjects are excluded if they have:
- An altered mental status precluding understanding or consenting for the procedure
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
Design:
- Number of participants: 16
- Number of sites: 1
- Recruitment time frame: 2 years
- Type of study: pilot study to validate an image analysis thermometry technique
- Patients undergoing clinically indicated hepatic ablations are eligible for this
protocol. As part of this study, one to two additional research scans of the liver may
be acquired during the ablation and analyzed separately with our software and compared
with thermocouple measurements. There will be no changes in devices, probes or
additional probe manipulations as part of this study. The operator will not modify the
procedure based on results of this software.
- 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:
- Subjects are eligible if:
--They are scheduled in interventional radiology for hepatic radiofrequency or microwave
ablation requiring thermocouples for monitoring
- Subjects are excluded if they have:
- An altered mental status precluding understanding or consenting for the procedure
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
Design:
- Number of participants: 16
- Number of sites: 1
- Recruitment time frame: 2 years
- Type of study: pilot study to validate an image analysis thermometry technique
- Patients undergoing clinically indicated hepatic ablations are eligible for this
protocol. As part of this study, one to two additional research scans of the liver may
be acquired during the ablation and analyzed separately with our software and compared
with thermocouple measurements. There will be no changes in devices, probes or
additional probe manipulations as part of this study. The operator will not modify the
procedure based on results of this software.
- 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.
EXCLUSION CRITERIA:
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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