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

NCT06261814 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: iRISID-2023-2142JT 33825R01CA194307
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (6)

• Recurrence

  Up to 6 months

• Sensitivity

  Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between hepatocellular carcinoma (HCC) and non-HCC and between all tumor subtypes.

  Up to 6 months

• Specificity

  Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

  Up to 6 months

• Positive predictive value

  Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

  Up to 6 months

• Negative predictive value

  Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

  Up to 6 months

• False discovery rate

  Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

  Up to 6 months

Secondary Outcomes (3)

• Residual tumor vacularity

  Up to 6 months

• Diagnostic performance for each imaging mode

  Up to 6 months

• Ability of the model to predict binary treatment response

  Up to 6 months

Study Arms (1)

Diagnostic (CEUS)

EXPERIMENTAL

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)

Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Contrast-Enhanced Ultrasound; Procedure: Transarterial Chemoembolization; Other: Medical Chart Review

Interventions

Sulfur Hexafluoride Lipid Microspheres DRUG

Given IV

Also known as: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres

Diagnostic (CEUS)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Diagnostic (CEUS)

Contrast-Enhanced Ultrasound PROCEDURE

Undergo CEUS

Also known as: CEUS

Diagnostic (CEUS)

Transarterial Chemoembolization PROCEDURE

Undergo TACE

Also known as: TACE, Chemoembolization

Diagnostic (CEUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• john eisenbrey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

John Eisenbrey, PhD

CONTACT

215-503-5188; john.eisenbrey@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: No Data Available

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)