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

Официальное название

2D and 3D Contrast Enhanced Ultrasound of Chemoembolization

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Sulfur Hexafluoride Lipid Microspheres
  Given IV
• Процедура Contrast-Enhanced Ultrasound
  Undergo CEUS
• Процедура Transarterial Chemoembolization
  Undergo TACE
• Другое Medical Chart Review
  Ancillary studies

Первичные конечные точки

• Recurrence [Срок оценки: Up to 6 months]
• Sensitivity [Срок оценки: Up to 6 months]
• Specificity [Срок оценки: Up to 6 months]
• Positive predictive value [Срок оценки: Up to 6 months]
• Negative predictive value [Срок оценки: Up to 6 months]
• False discovery rate [Срок оценки: Up to 6 months]

Вторичные конечные точки (3)

• Residual tumor vacularity [Срок оценки: Up to 6 months]
• Diagnostic performance for each imaging mode [Срок оценки: Up to 6 months]
• Ability of the model to predict binary treatment response [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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