Could a simple ultrasound replace liver biopsies for this rare disease?
NCT ID NCT07492862
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study explores whether a special ultrasound technique, called dynamic contrast-enhanced ultrasound (DCE-US), can diagnose porto-sinusoidal vascular disorder (PSVD) without needing a liver biopsy. Researchers will compare ultrasound images from 100 people with PSVD or cirrhosis to see if blood flow patterns differ. If it works, this painless test could make diagnosis easier and faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- contrast-enhanced ultrasound with VueBox software
- What this could lead to
- If successful, this could provide a noninvasive way to diagnose PSVD, avoiding the need for a liver biopsy.
- What could go wrong
- This is an early exploratory study with only 100 participants, so results may not be conclusive or widely applicable. The technique may not reliably distinguish PSVD from cirrhosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria - PSVD group * Histologically confirmed diagnosis of porto-sinusoidal vascular disease (PSVD); * Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding); * Age ≥ 18 years; * Ability to understand the study information and provide written informed consent; Inclusion criteria - Cirrhosis group * Diagnosis of liver cirrhosis confirmed by liver histology or, alternatively, by compatible findings on imaging, laboratory tests, and physical examination together with a positive history for at least one known cause of chronic liver disease; * Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding); * Age ≥ 18 years; * Ability to understand the study information and provide written informed consent. Exclusion criteria - PSVD group (cases) * Presence of other causes of portal hypertension, including but not limited to: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, or chronic cholestatic liver diseases; * Presence of portal, spleno-mesenteric, or hepatic vein thrombosis; * Prior hepatic or splenic surgery; * Presence of primary or secondary malignant liver tumors; * Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device; * Congenital anomalies of the liver or biliary tract; * History of heart failure; * Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome; * Inadequate sonographic visualization of the right hepatic lobe; * Pregnancy. Exclusion criteria - Cirrhosis group * Decompensated cirrhosis or Child-Pugh class C; * Cryptogenic cirrhosis; * Presence of other causes of portal hypertension (same list as for PSVD exclusions: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, chronic cholestatic diseases); * Presence of portal, spleno-mesenteric, or hepatic vein thrombosis; * Prior hepatic or splenic surgery; * Presence of primary or secondary malignant liver tumors; * Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device; * Congenital anomalies of the liver or biliary tract; * History of heart failure; * Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome; * Inadequate sonographic visualization of the right hepatic lobe; * Pregnancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168, Italy
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