NCT04720456CompletedPhase 2
SHAPE of Portal Hypertension in Children
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 4 Jan 2021
- Start date
- Nov 2021
- Primary completion date
- Aug 2025
- Lead sponsor
- Thomas Jefferson University
- Diseases
- High blood pressure
- NCT number
- NCT04720456
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From Nov 2021 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior liver transplant.
Other illness
- 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 Sonazoid
- Patients with chronic lung disease.
- Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
- Patients with significant heart disease or severe congenital heart disease
Lab values
- 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)
Other
- Subjects who are pregnant.
- Patients with biliary atresia with asplenia or polysplenia.
- Patients with cystic fibrosis.
- Adults not competent/impaired.
Who the study is looking for
- Patients with a diagnosis of chronic liver disease without portal hypertension.
- Patients with a diagnosis of chronic liver disease with portal hypertension.
Age in the registry: 6 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Children's Hospital Of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.