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Completed

NCT Number: NCT01906021

Study of New Software Used 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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Hepatic Cancer Hepatic Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Neoplasms, Liver

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

CT/CBCT thermometry method

Procedure

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

Ablation Probe

Procedure

Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern)

Primary outcomes

  1. To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method

    Time frame: two years

    Bayesian median estimate will be used.

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study title

Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations

Important dates

Study start
2013
Primary completion
2015
Study completion
2020
First posted
Jul 23, 2013
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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