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NCT Number: NCT06261814

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfur Hexafluoride Lipid Microspheres

Drug

Given IV

Other names: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres

Contrast-Enhanced Ultrasound

Procedure

Undergo CEUS

Other names: CEUS

Transarterial chemoembolization

Procedure

Undergo TACE

Other names: TACE, Chemoembolization

medical chart review

Other

Ancillary studies

Other names: Chart Review

Primary outcomes

  1. Recurrence

    Time frame: Up to 6 months

  2. Sensitivity

    Time frame: Up to 6 months

    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.

  3. Specificity

    Time frame: Up to 6 months

    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.

  4. Positive predictive value

    Time frame: Up to 6 months

    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.

  5. Negative predictive value

    Time frame: Up to 6 months

    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.

  6. False discovery rate

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. Residual tumor vacularity

    Time frame: Up to 6 months

    Will use diagnostic summary statistics and generalized estimating equations (GEE) logistic regression modeling. The bedside (interventional radiologist) versus offline (radiologist) reads will be compared using agreement, kappa statistics, and mixed modeling.

  2. Diagnostic performance for each imaging mode

    Time frame: Up to 6 months

    The diagnostic performance for each reader will be quantified from the volumetric contrast enhanced ultrasound exams and post-processed images. Diagnostic performance for each imaging mode will be compared across all readers using the GEE logistic regression approach. Quantitative H-scan data will be compared between complete and incomplete responders using multiple linear regression or GEE regression modeling, depending on how well assumptions hold for the former.

  3. Ability of the model to predict binary treatment response

    Time frame: Up to 6 months

    Model performance will be calculated using a leave-one-out cross-validation method to assess the ability of the model to predict binary treatment response. Accuracy, sensitivity and specificity will then be quantified and directly compared between 2 dimensional (D) and 3D datasets.

Study contacts

Contact information is provided by the study sponsor or research team.

John Eisenbrey, PhD

CONTACT

[email protected]

215-503-5188

Sponsors and collaborators

Lead sponsor

john eisenbrey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

2D and 3D Contrast Enhanced Ultrasound of Chemoembolization

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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