NCT05211388

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To rigorously test the feasibility of 3D echo decorrelation imaging to improve the reliability of clinical thermal ablation, decorrelation-controlled ablation will be assessed in a pilot treat-and-resect study. Patients previously scheduled for resection of metastatic liver tumors or benign liver tumors physiologically similar to hepatocellular carcinoma (HCC) (e.g., hepatocellular adenoma or focal nodular hyperplasia) will first undergo radiofrequency ablation (RFA) of their tumors, with real-time, 3D ultrasound echo decorrelation imaging of the treated region performed throughout each ablation. RFA will be performed in the same surgical procedure as the scheduled tumor resection, immediately prior to resection. Patients will be enrolled in two arms, the first undergoing RFA controlled by the RFA generator using manufacturer-specified algorithms, and the second undergoing RFA with echo decorrelation imaging providing an additional stopping criterion. For both arms, 3D maps of ablation zones will be constructed from stained tissue sections and rigidly registered to volumetric ultrasound images using the known tumor position and orientation relative to the ultrasound image volume. Overall ROC curves for prediction of local treatment will be constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone. The ability of echo decorrelation to predict and control clinical thermal ablation of human liver tumors will be directly tested by assessing and statistically comparing outcomes of the two study arms, including ROC curves, ablation volume and rate, and conformity to planned ablation zones.

Conditions

• Liver Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-11
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2022-01-27
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States