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

NCT ID: NCT06261814

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

No Data Available
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (CEUS)

Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.

Intervention(s)

Group Type EXPERIMENTAL

Sulfur Hexafluoride Lipid Microspheres

Intervention Type DRUG

Given IV

Contrast-Enhanced Ultrasound

Intervention Type PROCEDURE

Undergo CEUS

Transarterial Chemoembolization

Intervention Type PROCEDURE

Undergo TACE

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulfur Hexafluoride Lipid Microspheres

Given IV

Intervention Type DRUG

Contrast-Enhanced Ultrasound

Undergo CEUS

Intervention Type PROCEDURE

Transarterial Chemoembolization

Undergo TACE

Intervention Type PROCEDURE

Medical Chart Review

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumason SF6 Lipid Microspheres Sulfur Hexafluoride Lipid-type A Microspheres CEUS TACE Chemoembolization Chart Review

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled for TACE therapy of a liver tumor
* Be at least 18 years of age
* Be medically stable
* If a female of child-bearing age, must have a negative pregnancy test
* Have signed informed consent to participate in the study

Exclusion Criteria

* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
* Patients with known sensitivities to the components of lumason
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

john eisenbrey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

john eisenbrey

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

John Eisenbrey, PhD

Role: CONTACT

215-503-5188

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JT 33825

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA194307

Identifier Type: NIH

Identifier Source: secondary_id

View Link

iRISID-2023-2142

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.