SHAPE of Portal Hypertension in Children

Hypertension, Portal Clinical Trial

Official title:

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720456
• Other study ID #: 20F.728
• Secondary ID: R01DK118964
• Status: Recruiting
• Phase: Phase 2
• Start date: November 3, 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Thomas Jefferson University
• Contact: Morgan L Gabbert, MA
• Phone: 267-426-0820
• Email: gabbertm[@]email.chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

Drug:
• SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)
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)
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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Eisenbrey JR, Dave JK, Halldorsdottir VG, Merton DA, Miller C, Gonzalez JM, Machado P, Park S, Dianis S, Chalek CL, Kim CE, Baliff JP, Thomenius KE, Brown DB, Navarro V, Forsberg F. Chronic liver disease: noninvasive subharmonic aided pressure estimation — View Citation

Gupta I, Eisenbrey JR, Machado P, Stanczak M, Wessner CE, Shaw CM, Gummadi S, Fenkel JM, Tan A, Miller C, Parent J, Schultz S, Soulen MC, Sehgal CM, Wallace K, Forsberg F. Diagnosing Portal Hypertension with Noninvasive Subharmonic Pressure Estimates from — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%)		2 hours
Primary	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%		2 hours
Secondary	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)		on average 18 months
Secondary	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		2 hours
Secondary	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		2 hours
Secondary	Compare calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins to shear wave elastography values (in m/s) using regression analysis		2 hours