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SHAPE measurement for Portal Hypertension

Phase 3

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

Be scheduled for transjugular liver biopsy where HVPG measurements will be obtained (Cohort 1)

Have clinically significant portal hypertension undergoing routine HCC surveillance (Cohort 2)

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 18 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Study Summary

This trial will study if the SHAPE algorithm can accurately estimate portal pressures in patients with various degrees of liver disease, if it can predict the development of ascites and other liver-related events, and if it can be used to monitor treatment response in patients with portal hypertension.

Eligible Conditions

Portal Hypertension
Liver Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are planning to have a liver biopsy with measurements of hepatic venous pressure gradient (HVPG) taken.

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You have serious liver blood pressure problems and are getting regular check-ups for liver cancer.

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You have been diagnosed with portal hypertension and are starting treatment with non-selective β-blockers.

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You have serious liver-related issues and are scheduled for a procedure to check for swollen veins in your stomach or esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects who develop ascites during follow-up

Number of subjects who experience clinical decompensation events (including the development of variceal bleeding) during follow-up

Number of subjects who present with esophageal or gastric varices on endoscopy

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Reproducibility - Cohort 1Experimental Treatment2 Interventions

Patients scheduled for hepatic venous pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE procedures using different ultrasound contrast agents (Definity and Sonazoid in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare). Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min. Two vials with 3 mL of Definity will be mixed and diluted in 50 mL of normal saline, yielding a concentration of 49.4 μL/mL, and infused at a rate of at least 4 ml/min.

Group II: New β-blockers - Cohort 3Experimental Treatment1 Intervention

Patients newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

Group III: HCC monitoring - Cohort 2Experimental Treatment1 Intervention

Patients identified as having CSPH will be monitored every 6 ± 2 months to check for HCC by SHAPE with Sonazoid for the duration of this project ( for 18-24 months on average). Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

Group IV: Ccreening for varices - Cohort 4Experimental Treatment1 Intervention

Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices according to the Baveno VI or the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index and FIB-4 will undergo a SHAPE examination. Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SHAPE measurement (Sonazoid ultrasoud contrast agent)

2015

Completed Phase 4

~180

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,296 Previous Clinical Trials

4,211,268 Total Patients Enrolled

4 Trials studying Portal Hypertension

1,012 Patients Enrolled for Portal Hypertension

University of BernOTHER

335 Previous Clinical Trials

1,376,885 Total Patients Enrolled

Thomas Jefferson UniversityLead Sponsor

431 Previous Clinical Trials

140,828 Total Patients Enrolled

1 Trials studying Portal Hypertension

178 Patients Enrolled for Portal Hypertension

Media Library

SHAPE measurement (Sonazoid ultrasoud contrast agent) Clinical Trial Eligibility Overview. Trial Name: NCT05470205 — Phase 3

Portal Hypertension Research Study Groups: Reproducibility - Cohort 1, HCC monitoring - Cohort 2, New β-blockers - Cohort 3, Ccreening for varices - Cohort 4

Portal Hypertension Clinical Trial 2023: SHAPE measurement (Sonazoid ultrasoud contrast agent) Highlights & Side Effects. Trial Name: NCT05470205 — Phase 3

SHAPE measurement (Sonazoid ultrasoud contrast agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470205 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for patients who want to participate in this clinical trial?

"The clinicaltrial.gov website informs us that this study has completed recruitment for participants. This trial was posted on August 15th, 2020 and the last update was July 20th, 2022. There are 1058 other trials currently recruiting patients."

Answered by AI