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

Not Applicable

Withdrawn

• Conditions: Liver Tumor
• Interventions: Procedure: RFA controlled using standard manufacturer-specified algorithms; Procedure: RFA controlled using echo decorrelation imaging

• Registration Number: NCT05211388
• Lead Sponsor: University of Cincinnati

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Study Start: 2022-07-11
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥18 years.
2. Scheduled for resection of at least one confirmed primary or metastatic liver tumor with estimated diameter <5 cm at the University of Cincinnati Medical Center (UCMC).
3. Patients may have other disease (typically cirrhosis, hepatitis B or hepatitis C) for primary liver cancer patients and extrahepatic cancer (typically colorectal) for metastatic liver cancer patients.
4. Ability to understand and the willingness to sign the written research informed consent document for this study.

Exclusion Criteria

1. The tumor for which the resection is scheduled is greater than or equal to 5 cm in diameter.
2. The tumor for which the resection is scheduled has received: prior ablation; chemoembolization; or, other treatment which in the opinion of the PI would disqualify a patient from participation.
3. Radiofrequency ablation (RFA) is contra-indicated for safety reasons in the opinion of the PI and/or clinical treatment team according to current standards of care (e.g., tumor adjacent to the heart, bowel, gall bladder, or bile ducts; impaired liver function; implanted cardiac devices).
4. Proceduralist assessment that research-specific radiofrequency ablation or intraoperative ultrasound imaging would cause substantial patient risk.
5. Pregnant women, prisoners, institutionalized individuals, or other individuals from vulnerable populations.
6. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
arm 1: generator-controlled RFA	RFA controlled using standard manufacturer-specified algorithms	In up to 6 patients (arm 1: generator-controlled RFA), RFA will be performed directly following manufacturer-specified algorithms, with recording of 3D ultrasound echo decorrelation images during ablation.
arm 2: imaging-controlled RFA	RFA controlled using echo decorrelation imaging	In up to 6 additional patients (arm 2: imaging-controlled RFA), real-time, 3D echo decorrelation imaging during ablation will provide an additional treatment end point.

Primary Outcome Measures

Name	Time	Method
Conformity with planned ablation zone	2 years	Dice coefficients between segmented ablation volumes and targeted ablation zones (dimensionless, values between 0 and 1). Determined separately for each arm.
Area under ROC curves	2 years	Area under ROC curves for prediction of local ablation (dimensionless, possible values between 0 and 1). Determined separately for each arm.
Ablation volumes	2 years	Volumes (ml) of segmented ablation zones. Determined separately for each arm.
Thermal ablation rates	2 years	Ablation rates (ml/min), defined as ablation volumes (ml) divided by duration of radiofrequency ablation (min). Determined separately for each arm.
ROC curves for local prediction of ablation of human liver tumors and concomitant diseased liver.	2 years	Receiver operating characteristic (ROC) curves for prediction of local ablation (dimensionless), constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone (dimensionless, possible values between 0 and 1). Determined separately for each arm.

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States