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Procedure

Noninvasive Ultrasound Technique for Portal Hypertension

Phase 2

Recruiting

Led By Flemming Forsberg, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of chronic liver disease without portal hypertension

Patients with a diagnosis of chronic liver disease with portal hypertension

Must not have

Patients with cystic fibrosis

Patients with prior liver transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.

Who is the study for?

This trial is for children with chronic liver disease, both with and without portal hypertension. It's not for kids with lung issues, portal vein problems, heart disease, or those who've had a liver transplant. Also excluded are pregnant subjects or those allergic to egg products or certain ultrasound contrast agents.

What is being tested?

The trial tests SHAPE measurements using two different ultrasound contrast agents (Sonazoid and Lumason) to diagnose portal hypertension noninvasively in children. This could help monitor the progression of liver disease and risk of complications early on.

What are the potential side effects?

Potential side effects may include allergic reactions related to the components of Sonazoid and Lumason such as polyethylene glycol or egg-derived substances. However, specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic liver disease but no portal hypertension.

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I have chronic liver disease with increased blood pressure in the portal vein.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cystic fibrosis.

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I have had a liver transplant in the past.

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I am not able to make decisions for myself due to a mental or physical condition.

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I have biliary atresia and either missing or multiple spleens.

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I am allergic to Lumason or its ingredients.

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I have a long-term lung condition.

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I have a blood clot or abnormality in the main liver vein.

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I have serious heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SHAPE with SonazoidExperimental Treatment1 Intervention

Up to 60 children (6-21 years of age) with a diagnosis of chronic liver disease, including some who will have portal hypertension who are followed at The Children's Hospital of Philadelphia (CHOP) will be enrolled in this arm. A SHAPE measurement using the ultrasound contrast agent Sonazoid® (perfluorobutane microbubbles) will be performed during a single visit. A dose of three vials with 16 μL each of microbubbles will be prepared. An infusion of the ultrasound contrast agent at the rate of 0.18 mL/kg/hour will be co-infused with an infusion of saline at the rate of 120 mL/hour resulting in an effective dosage of 1.44 μL microbubbles/kg/hour as per the FDA approved IND through an IV line in a peripheral vein. The total duration of contrast agent infusion is expected to range from 4 to 8 minutes, which includes a 2 min calibration period followed by 2-6 minutes of SHAPE acquisition (i.e., ultrasound imaging).

Group II: Longitudinal SHAPEExperimental Treatment2 Interventions

SHAPE will be used to monitor subjects identified in the initial examination as having portal hypertension for up to 18 months. These subjects will undergo laboratory testing every 6 months as a part of their clinical standard of care. During these times the SHAPE examination will also be repeated using the same ultrasound contrast agent and infusion methodologies (including dosages) as during the initial study.

Group III: SHAPE with LumasonActive Control1 Intervention

Up to 60 children (6-21 years of age) with a diagnosis of chronic liver disease, including some who will have portal hypertension who are followed at CHOP will be enrolled in this arm. A SHAPE measurement using the ultrasound contrast agent LUMASON® (sulfur hexafluoride lipid-type A microspheres) will be performed during a single visit. Two doses of 0.03 mL/kg (or 2.4 mL maximum) as per package labeling will be prepared and mixed with saline at a 1:10 dilution in a 50 ml bag of saline. The diluted preparation of Lumason will be through an IV line in a peripheral vein up to 4 mL/min using an infusion setup. The total duration of contrast agent infusion is expected to range from 4 to 8 minutes, which includes a 2 min calibration period followed by 2-6 minutes of SHAPE acquisition (i.e., ultrasound imaging).

0 / 10Eligibility criteria met