SHAPE measurement (Sonazoid ultrasoud contrast agent) for Liver Diseases

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Thomas Jefferson University, Dept of Radiology, Philadelphia, PA
Liver Diseases+3 More
SHAPE measurement (Sonazoid ultrasoud contrast agent) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using different ultrasound contrast agents (Definity [Lantheus Medical Imaging, N Bilerica, MA, USA] and Sonazoid [GE Healthcare, Oslo, Norway] in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the reproducibility of the SHAPE algorithm. Cohort 2: Patients identified as having clinically significant portal hypertension (CSPH) will be monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average). These subjects will have follow-up ultrasound scans every 6 ± 2 months to check for hepatocellular carcinoma (HCC) (using the Barcelona-Liver Cancer staging system) as well as ascites and at those times a repeat SHAPE examination will be performed. Liver stiffness values will be measured with elastography as well. This cohort will examine if serial SHAPE can accurately predict development of ascites and other liver related events in patients with compensated cirrhosis undergoing routine HCC surveillance in a multi-center setting. Cohort 3: Subjects newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE and results compared to elastography measurements of liver stiffness with standard assessments (e.g., serum liver function tests and measurement of spleen size as well as platelet count). This cohort will establish if SHAPE can be used to monitor treatment response in patients identified with portal hypertension. Cohort 4: Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices relative to the Baveno VI and the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index will undergo a SHAPE examination. This cohort will compare the predictive ability of SHAPE for allocating patients with compensated advanced chronic liver disease to screening of varices compared to the current standard of care.

Eligible Conditions

  • Liver Diseases
  • Portal Hypertension

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: up to 18 months

baseline
Number of subjects who present with esophageal or gastric varices on endoscopy
during procedure
Reproducibility of SHAPE liver pressure measurements
up to 18 months
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

New β-blockers - Cohort 3
1 of 4
Reproducibility - Cohort 1
1 of 4
HCC monitoring - Cohort 2
1 of 4
Ccreening for varices - Cohort 4
1 of 4
Experimental Treatment

660 Total Participants · 4 Treatment Groups

Primary Treatment: SHAPE measurement (Sonazoid ultrasoud contrast agent) · No Placebo Group · Phase 3

New β-blockers - Cohort 3
Drug
Experimental Group · 1 Intervention: SHAPE measurement (Sonazoid ultrasoud contrast agent) · Intervention Types: Drug
Reproducibility - Cohort 1Experimental Group · 2 Interventions: SHAPE measurement (Sonazoid ultrasoud contrast agent), SHAPE measurement (Definity ultrasoud contrast agent) · Intervention Types: Drug, Drug
HCC monitoring - Cohort 2
Drug
Experimental Group · 1 Intervention: SHAPE measurement (Sonazoid ultrasoud contrast agent) · Intervention Types: Drug
Ccreening for varices - Cohort 4
Drug
Experimental Group · 1 Intervention: SHAPE measurement (Sonazoid ultrasoud contrast agent) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SHAPE measurement (Sonazoid ultrasoud contrast agent)
2015
Completed Phase 4
~180

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months
Closest Location: Thomas Jefferson University, Dept of Radiology · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
2019First Recorded Clinical Trial
2 TrialsResearching Liver Diseases
2 CompletedClinical Trials

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
393 Previous Clinical Trials
125,813 Total Patients Enrolled
2 Trials studying Liver Diseases
778 Patients Enrolled for Liver Diseases
University of BernOTHER
292 Previous Clinical Trials
1,255,317 Total Patients Enrolled
1 Trials studying Liver Diseases
198 Patients Enrolled for Liver Diseases
University of PennsylvaniaOTHER
1,797 Previous Clinical Trials
36,105,902 Total Patients Enrolled
6 Trials studying Liver Diseases
973 Patients Enrolled for Liver Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,094 Previous Clinical Trials
5,050,833 Total Patients Enrolled
56 Trials studying Liver Diseases
43,386 Patients Enrolled for Liver Diseases
Flemming Forsberg, PhDPrincipal InvestigatorThomas Jefferson University
11 Previous Clinical Trials
730 Total Patients Enrolled
1 Trials studying Liver Diseases
178 Patients Enrolled for Liver Diseases

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age.
You are medically stable.
You are a female of child-bearing potential
• You are scheduled for liver biopsy where HVPG measurements will be obtained.
• Have clinically significant portal hypertension and be scheduled for endoscopy to screen for varices.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References