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Study of New Software Used During Ablations

NCT01906021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-12-10

No results posted yet for this study

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.

Conditions

  • Liver Cancer
  • Neoplasms, Liver
  • Hepatic Neoplasms
  • Hepatic Cancer

Interventions

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)

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Bradford J Wood, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-23
Primary Completion
2015-08-01
Completion
2020-12-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906021 on ClinicalTrials.gov