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

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

NCT ID: NCT06261814

Condition: Liver Neoplasms

Conditions: Official terms:
Liver Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: No Data Available

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sulfur Hexafluoride Lipid Microspheres
Description: Given IV
Arm group label: Diagnostic (CEUS)

Other name: Lumason

Other name: SF6 Lipid Microspheres

Other name: Sulfur Hexafluoride Lipid-type A Microspheres

Intervention type: Procedure
Intervention name: Contrast-Enhanced Ultrasound
Description: Undergo CEUS
Arm group label: Diagnostic (CEUS)

Other name: CEUS

Intervention type: Procedure
Intervention name: Transarterial Chemoembolization
Description: Undergo TACE
Arm group label: Diagnostic (CEUS)

Other name: TACE

Other name: Chemoembolization

Intervention type: Other
Intervention name: Medical Chart Review
Description: Ancillary studies
Arm group label: Diagnostic (CEUS)

Other name: Chart Review

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.

Detailed 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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sidney Kimmel Cancer Center at Thomas Jefferson University

Address:
City: Philadelphia
Zip: 19107
Country: United States

Start date: August 31, 2024

Completion date: January 1, 2028

Lead sponsor:
Agency: john eisenbrey
Agency class: Other

Source: Thomas Jefferson University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06261814