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NCT Number: NCT04720456

SHAPE of Portal Hypertension in Children

Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, 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.

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Key information

Conditions

Hypertension, Portal Digestive System Diseases Liver Diseases

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Kassa Darge, MD, PhD

SUB_INVESTIGATOR

Kathleen M Loomes, MD

SUB_INVESTIGATOR

Morgan L Gabbert, MA

CONTACT

[email protected]

267-426-0820

Ryne Didier, MD

SUB_INVESTIGATOR

Sudha A Anupindi, MD

PRINCIPAL_INVESTIGATOR

Susan J Back, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of chronic liver disease without portal hypertension.
  • Patients with a diagnosis of chronic liver disease with portal hypertension.

Exclusion criteria

  • Subjects who are pregnant.
  • Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
  • Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
  • History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
  • History of allergic reaction to Sonazoid
  • Patients with biliary atresia with asplenia or polysplenia.
  • Patients with prior liver transplant.
  • Patients with cystic fibrosis.
  • Patients with chronic lung disease.
  • Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
  • Adults not competent/impaired.
  • Patients with significant heart disease or severe congenital heart disease

Treatment and study plan

SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)

Drug

The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.

SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)

Drug

The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.

Primary outcomes

  1. The rate (%) of adverse events that occur with Sonazoid compared to the current rate of adverse events that have been reported in the Lumason package insert for pediatric use (0.001%)

    Time frame: 2 hours

  2. Calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins will differentiate between the portal hypertension and non-portal hypertension groups with an accuracy of 94%

    Time frame: 2 hours

Secondary outcomes

  1. Changes in calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins over time will predict the development of complications of portal hypertension (variceal bleeding, ascites, hepatopulmonary syndrome, etc)

    Time frame: on average 18 months

  2. Calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins and liver fibrosis stage (on a scale from 0-4 as determined by liver biopsy) will correlate with a p<0.05

    Time frame: 2 hours

  3. Compare the calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins obtained with Lumason and Sonazoid, respectively, for their ability to differentiate between the portal hypertension and non-portal hypertension groups

    Time frame: 2 hours

  4. Compare calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins to shear wave elastography values (in m/s) using regression analysis

    Time frame: 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan L Gabbert, MA

CONTACT

[email protected]

267-426-0820

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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