Study of New Software Used During Ablations

National Institutes of Health Clinical Center (CC)

Status

Completed

Conditions

Neoplasms, Liver

Hepatic Cancer

Hepatic Neoplasms

Liver Cancer

Treatments

Procedure: CT/CBCT thermometry method

Procedure: Ablation Probe

Study type

Interventional

Funder types

NIH

Identifiers

NCT01906021

130178

13-CC-0178

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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