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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on average 18 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have chronic liver disease but no portal hypertension.
Select...
I have chronic liver disease with increased blood pressure in the portal vein.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on average 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on average 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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%
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%)
Secondary outcome measures
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
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)
Compare calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins to shear wave elastography values (in m/s) using regression analysis
+1 moreTrial 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).
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,369 Total Patients Enrolled
2 Trials studying Portal Hypertension
838 Patients Enrolled for Portal Hypertension
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,939 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,174 Total Patients Enrolled
5 Trials studying Portal Hypertension
1,672 Patients Enrolled for Portal Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cystic fibrosis.I have had a liver transplant in the past.You have had an allergic reaction to Sonazoid in the past.I am not able to make decisions for myself due to a mental or physical condition.I have biliary atresia and either missing or multiple spleens.You have had a severe allergic reaction to eggs or egg products in the past.I am allergic to Lumason or its ingredients.I have a long-term lung condition.I have a blood clot or abnormality in the main liver vein.I have chronic liver disease but no portal hypertension.I have serious heart disease.I have chronic liver disease with increased blood pressure in the portal vein.
Research Study Groups:
This trial has the following groups:- Group 1: SHAPE with Sonazoid
- Group 2: SHAPE with Lumason
- Group 3: Longitudinal SHAPE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being accepted for this clinical trial?
"Yes, this information is accurate. The latest update on the clinical trial was on 1/20/2022 and it is still recruiting patients as of right now."
Answered by AI
Could I potentially participate in this clinical trial?
"Potential participants of this hypertension study must have portal hypertension and be between the ages of 6 to 21. Around 120 children will be accepted into the trial."
Answered by AI
Is it legal to use Sonazoid (perfluorobutane microbubbles) in ultrasounds for SHAPE measurements?
"SHAPE measurement, which uses the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles), is considered safe based on data from Phase 2 clinical trials."
Answered by AI
Does this research allow people who are middle-aged to participate?
"As this study's eligibility requirements detail, children aged 6 to 21 are able to enroll."
Answered by AI
How many people are currently signed up to participate in this trial?
"That is correct, the online information does show that this study needs volunteers. The posting date was November 3rd 2021 and the most recent update was on January 20th 2022. They are looking for a total of 120 patients from 1 location."
Answered by AI
What other research exists in this field?
"The first study on SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles) was conducted in 2017 by Bracco Diagnostics, Inc. Following this initial research, which involved 125 patients, SHAPE measurement received its Phase < 1 drug approval. Today, there are 19 live studies being conducted across 10 cities and 3 countries."
Answered by AI
Could you please tell us what other scientific papers have been published that mention using the medical imaging agent Sonazoid (perfluorobutane microbubbles) to measure SHAPE?
"There are currently 19 clinical trials researching the use of Sonazoid, an ultrasound contrast agent, in SHAPE measurement. Of these 19 trials, 3 are in Phase 3. Most of the research is being conducted in Philadelphia, but there are 23 total locations running these types of trials."
Answered by AI
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