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

Liver Neoplasms Clinical Trial

Official title:

2D and 3D Contrast Enhanced Ultrasound of Chemoembolization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261814
• Other study ID #: iRISID-2023-2142
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 31, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: John Eisenbrey, PhD
• Phone: 215-503-5188
• Email: john.eisenbrey[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. To evaluate the sensitivity and specificty 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: January 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Drug:
• Sulfur Hexafluoride Lipid Microspheres
Given IV

Procedure:
• Contrast-Enhanced Ultrasound
Undergo CEUS
• Transarterial Chemoembolization
Undergo TACE

Other:
• Medical Chart Review
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
john eisenbrey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	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
Primary	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
Primary	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
Primary	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
Primary	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	Residual tumor vacularity	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.	Up to 6 months
Secondary	Diagnostic performance for each imaging mode	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.	Up to 6 months
Secondary	Ability of the model to predict binary treatment response	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.	Up to 6 months