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NCT05470205 · ClinicalTrials.gov registry record · Phase 3
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
A Phase 3 study of Liver Diseases and Portal Hypertension, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 3
- Study locations
NCT05470205 is a Phase 3 study of Liver Diseases and Portal Hypertension that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 660 participants, below the 61,138-participant average among 33 other Liver Diseases trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05470205, a Phase 3 study of Liver Diseases and Portal Hypertension, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 3
- Study locations
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 hy
Conditions Studied
Interventions
- DRUG SHAPE measurement (Sonazoid ultrasoud contrast agent)
- DRUG SHAPE measurement (Definity ultrasoud contrast agent)
Study Locations (3)
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University, Dept of Radiology - Philadelphia
Other
- University of Bern - Bern
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05470205
The ClinicalTrials.gov registry entry for NCT05470205 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61,138-participant average among 33 other Liver Diseases trials with a reported enrollment target (99% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Liver Diseases appearing as the primary indexed condition, and to 2 interventions - of which SHAPE measurement (Sonazoid ultrasoud contrast agent) is the first listed.
NCT05470205 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT05470205 about?
NCT05470205 is a clinical study titled "Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal". 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 cri...
What is the current status of trial NCT05470205?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2022-11-28. Estimated completion is 2026-04-30.
What conditions does trial NCT05470205 study?
This clinical trial studies the following conditions: Liver Diseases, Portal Hypertension.
What interventions are being tested in trial NCT05470205?
The interventions under investigation include: SHAPE measurement (Sonazoid ultrasoud contrast agent) (DRUG), SHAPE measurement (Definity ultrasoud contrast agent) (DRUG).
Who is sponsoring clinical trial NCT05470205?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05470205 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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