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Treat-and-resect Study of Echo Decorrelation Imaging-controlled Radiofrequency Ablation in Liver Tumors

NCT05211388 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-29

No results posted yet for this study

Summary

This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure reliable tumor treatment. The purpose of this study is to determine the ability of ultrasound echo decorrelation to successfully predict complete ablation of human hepatocellular carcinoma, concomitant diseased liver, and metastatic liver cancer and to determine the potential of echo decorrelation imaging to provide effective real-time control of radiofrequency ablation (RFA) in liver tumors.

Conditions

  • Liver Tumor

Interventions

PROCEDURE

RFA controlled using echo decorrelation imaging

The tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, with echo decorrelation imaging providing an additional stopping criterion. The targeted ablation zone will be subdivided into one or more contiguous control subvolumes encompassing the tumor. An echo decorrelation threshold will be chosen to provide a target specificity (e.g. 90%) for local ablation prediction, based on ROC curve analysis for ablation prediction in clinical RFA and MWA as well as in controlled ablation of ex vivo human liver tumors. Controlled RFA treatments will proceed until the average cumulative decorrelation exceeds this predetermined threshold within each control subvolume. To avoid compromising patient safety, treatments will not be extended beyond manufacturer-specified end points.

PROCEDURE

RFA controlled using standard manufacturer-specified algorithms

The tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, e.g. based on temperatures measured by thermocouples integrated into the RFA probe. 3D echo decorrelation imaging will be performed in real time during ablation, but will not be used to modify treatments.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • T. Douglas Mast, PhD · University of Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2024-01-15
Completion
2024-01-15

Countries

  • United States

Study Locations

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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 NCT05211388 on ClinicalTrials.gov