NCT06261814

Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors

2D and 3D Contrast Enhanced Ultrasound of Chemoembolization

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: john eisenbrey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the sensitivity and specificity of CEUS for the evaluation of TACE treatment response in a variety of solid liver tumors (years 1-4). SECONDARY OBJECTIVES: I. To determine the ability of CEUS to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4). II. To explore a variety of advanced imaging approaches to improve on the suboptimal specificity of CEUS for identifying residual viable tumor following TACE (years 1-5). III. To investigate the ability of CEUS obtained prior to TACE to quantitatively assess tumor vascular morphology and predict response to therapy (years 2-5). EXPLORATORY OBJECTIVE: I. Use acquired B-mode in-phase and quadrature (IQ) data for H-scan imaging. OUTLINE: Patients receive sulfur hexafluoride lipid microspheres (Lumason) intravenously (IV) and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE. After completion of study treatment, patients are followed up at 6 months.

Conditions

• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	Sulfur Hexafluoride Lipid Microspheres	Given IV
PROCEDURE	Contrast-Enhanced Ultrasound	Undergo CEUS
PROCEDURE	Transarterial Chemoembolization	Undergo TACE
OTHER	Medical Chart Review	Ancillary studies

Timeline

• Start date: 2024-08-07
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2024-02-15
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study