Study of New Software Used During Ablations

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01906021
First received: July 19, 2013
Last updated: May 9, 2014
Last verified: April 2014
  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
Liver Cancer
Neoplasms, Liver
Hepatic Neoplasms
Hepatic Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To correlate the ablation zone as determined on follow-up imaging and with the temperature map as determined by the non-invasive thermomap [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate the ablation zone as determined on follow-up imaging and with the temperature map as determined by the non-invasive thermomap [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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

Contacts
Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov
Contact: Nadine Abi-Jaoudeh, M.D. (301) 402-1386 abijaoudehn@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Nadine Abi-Jaoudeh, 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: May 9, 2014
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:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014