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Recruiting NCT06261814

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

Phase II Interventional Liver Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Transarterial Chemoembolization, Medical Chart Review.
Who it may be relevant to
Registry conditions: Liver Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

2D and 3D Contrast Enhanced Ultrasound of Chemoembolization

Overview

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.

Interventions

  • Drug Sulfur Hexafluoride Lipid Microspheres
    Given IV
  • Procedure Contrast-Enhanced Ultrasound
    Undergo CEUS
  • Procedure Transarterial Chemoembolization
    Undergo TACE
  • Other Medical Chart Review
    Ancillary studies

Primary outcome measures

  • Recurrence [Time frame: Up to 6 months]
  • Sensitivity [Time frame: Up to 6 months]
  • Specificity [Time frame: Up to 6 months]
  • Positive predictive value [Time frame: Up to 6 months]
  • Negative predictive value [Time frame: Up to 6 months]
  • False discovery rate [Time frame: Up to 6 months]
Secondary outcome measures (3)
  • Residual tumor vacularity [Time frame: Up to 6 months]
  • Diagnostic performance for each imaging mode [Time frame: Up to 6 months]
  • Ability of the model to predict binary treatment response [Time frame: Up to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT06261814 · iRISID-2023-2142 · JT 33825 · R01CA194307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗