Noninvasive ultrasound technique for diagnosing portal hypertension in children
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children
This study is testing a new ultrasound method to see if it can safely and effectively diagnose portal hypertension in children.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04720456 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of a noninvasive ultrasound technique called subharmonic aided pressure estimation (SHAPE) for diagnosing portal hypertension in children. The study will utilize two ultrasound contrast agents, Sonazoid and Lumason, to assess their effectiveness in monitoring disease progression and risk of complications associated with portal hypertension. Given the challenges in early diagnosis and the high incidence of life-threatening complications in affected children, this approach aims to provide a reliable diagnostic tool that could improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with chronic liver disease, both with and without portal hypertension.
Not a fit: Patients who are pregnant, have a history of severe allergies to the contrast agents, or have certain chronic conditions like cystic fibrosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective method for early diagnosis of portal hypertension in children, potentially reducing mortality rates associated with the condition.
How similar studies have performed: While the use of noninvasive ultrasound techniques is gaining traction, this specific approach using SHAPE for portal hypertension in children is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Flemming Forsberg, PhD — Thomas Jefferson University
- Study coordinator: Morgan L Gabbert, MA
- Email: gabbertm@email.chop.edu
- Phone: 267-426-0820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.