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Could a simple ultrasound replace liver biopsies for this rare disease?

NCT ID NCT07492862

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168, Italy

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