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临床试验/NCT06797193
NCT06797193招募中不适用

Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension

Mayo Clinic6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月13日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
60
试验地点
6
主要终点
Clinically significant portal hypertension (PH)

研究概览

简要总结

This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.

II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.

OUTLINE:

Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures
  • Adult patients (age of 18 years or older)
  • If a female of child-bearing potential, must have a negative pregnancy test
  • Be scheduled for HVPG measurement

排除标准

  • Patients who are unable to provide consent
  • Females who are pregnant or nursing
  • Patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)

研究组 & 干预措施

Diagnostic (Definity, SHAPE)

Experimental

Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

干预措施: Electronic Health Record Review (Other)

Diagnostic (Definity, SHAPE)

Experimental

Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

干预措施: Perflutren Lipid Microspheres (Drug)

Diagnostic (Definity, SHAPE)

Experimental

Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

干预措施: Liver Biopsy (Procedure)

Diagnostic (Definity, SHAPE)

Experimental

Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

干预措施: Medical Device Usage and Evaluation (Other)

Diagnostic (Definity, SHAPE)

Experimental

Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

干预措施: Ultrasound Imaging (Procedure)

结局指标

主要结局

Clinically significant portal hypertension (PH)

时间窗: Baseline (at time of ultrasound)

Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.

Diagnostic confidence

时间窗: Baseline (at time of ultrasound)

Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaydev K. Dave, PhD

Principal Investigator

Mayo Clinic

研究点 (6)

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