Study of New Software Used During Ablations

NCT01906021 | Completed

• 2 other identifiers: 13017813-CC-0178
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thermomap; Hepatic Lesions; Radiofrequency Ablation; Microwave; Non-Invasive Technique

Outcome Measures

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

  Bayesian median estimate will be used.

  two years

Study Arms (1)

1

EXPERIMENTAL

Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements

Procedure: CT/CBCT thermometry method; Procedure: Ablation Probe

Interventions

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

1

Ablation Probe PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Cho YK, Rhim H, Noh S. Radiofrequency ablation versus surgical resection as primary treatment of hepatocellular carcinoma meeting the Milan criteria: a systematic review. J Gastroenterol Hepatol. 2011 Sep;26(9):1354-60. doi: 10.1111/j.1440-1746.2011.06812.x.

  PMID: 21679247 BACKGROUND

• Dodd GD 3rd, Frank MS, Aribandi M, Chopra S, Chintapalli KN. Radiofrequency thermal ablation: computer analysis of the size of the thermal injury created by overlapping ablations. AJR Am J Roentgenol. 2001 Oct;177(4):777-82. doi: 10.2214/ajr.177.4.1770777.

  PMID: 11566672 BACKGROUND

• Lencioni R, Crocetti L. Image-guided thermal ablation of hepatocellular carcinoma. Crit Rev Oncol Hematol. 2008 Jun;66(3):200-7. doi: 10.1016/j.critrevonc.2008.01.003. Epub 2008 Mar 4.

  PMID: 18304832 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Bradford J Wood, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 23, 2013
• Study Start: September 23, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 8, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)