Study of New Software Used During Ablations
Condition: Liver Cancer; Neoplasms, Liver; Hepatic Neoplasms; Hepatic Cancer
MeSH terms: Neoplasms; Liver Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): CT/CBCT thermometry method; Ablation Probe
Intervention type(s): Procedure; Procedure
Intervention description(s): The study consists of acquiring one or maximum two additional CT or CBCT of the liver during hepatic RFA or MWA and analyzing the images to obtain a temperature map; Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Thermomap; Hepatic Lesions; Radiofrequency Ablation; Microwave; Non-Invasive Technique