Study of New Software Used During Ablations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01906021
First received: July 19, 2013
Last updated: August 7, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Neoplasms, Liver
Hepatic Neoplasms
Hepatic Cancer
Procedure: CT/CBCT thermometry method
Procedure: Ablation Probe
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: July 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements
Procedure: CT/CBCT thermometry method
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
Procedure: Ablation Probe
Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern)

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 software.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906021

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01906021     History of Changes
Other Study ID Numbers: 130178, 13-CC-0178
Study First Received: July 19, 2013
Last Updated: August 7, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Thermomap
Hepatic Lesions
Radiofrequency Ablation
Microwave
Non-Invasive Technique

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on August 27, 2015