Porto-sinusoidal Vascular Liver DisorderCEUS-PSVDNCT07492862
Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
A study testing Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software in people with Porto-sinusoidal Vascular Liver Disorder and Liver Cirrhosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis, Portal Hypertension, Noncirrhotic
- What is being tested?
- Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Assunta Zocco contact
mariaassunta.zocco@policlinicogemelli.it; raffaele.borriello@unicatt.it
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
Maria Assunta Zocco, +39 0630155057, mariaassunta.zocco@policlinicogemelli.it ; raffaele.borriello@unicatt.it
About this study
Official title: Explorative Study for the Application of Dynamic Contrast-enhanced Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests.
Contrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes.
To date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.
- Conditions
- Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis, Portal Hypertension, Noncirrhotic, Portal Hypertension Related to Cirrhosis, Ultrasound Elastography, Contrast-enhanced Ultrasound
- Being tested
- Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software
- Keywords
- porto-sinusoidal vascular liver disorder, liver cirrhosis, liver ultrasound, ultrasound elastography, dynamic contrast-enhanced ultrasound, chronic liver disease
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox SoftwareDevice
Patients from the two arms will undergoing dynamic contrast-enhanced ultrasound, and CEUS videoclips will be analyzed through the software VueBox to evaluate perfusion parameters. These parameters will be compared among the two arms and integrated with other ultrasound-derived data to analyze differences and to elaborate a multiparametric diagnostic score
| Study group | Role | What they receive |
|---|---|---|
| PSVD (Porto-Sinusoidal Vascular Disorder) | Experimental | Participants with confirmed porto-sinusoidal vascular disease undergoing DCE-US with quantitative perfusion analysis using the VueBox software device Receives: Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software |
| Cirrhosis | Experimental | Participants with confirmed liver cirrhosis undergoing DCE-US with quantitative perfusion analysis using the VueBox software device Receives: Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak enhancement (PE) measured on DCE-US (VueBox)
Maximum intensity of the signal in the time-intensity curve at dynamic contrast-enhanced ultrasound
Measured: Baseline
Time to peak (TTP) measured on DCE-US (VueBox)
The time required from the beginning of the exam to reach the peak enhancement
Measured: Baseline
Area under the time-intensity curve (AUC) measured on DCE-US (VueBox)
The total area under the time-intensity curve reflecting the quantity of contrast media passed through the region of interest
Measured: Baseline
Wash-in rate (slope) measured on DCE-US (VueBox)
Tangent at the ascending part of the time-intensity curve
Measured: Baseline
Mean Transit Time measured on DCE-US (VueBox)
Mean time taken by contrast to pass through the ROI
Measured: Baseline
Rise Time measured on DCE-US (VueBox)
Time from peak enhancement to point where tangent of ascending curve across x-axis
Measured: Baseline
Wash-out rate measured on DCE-US (VueBox)
The tangent at the descending part of the time-intensity curve
Measured: Baseline
Secondary outcomes (5)
Diagnostic sensitivity and specificity of predefined perfusion parameter cut-offs for identifying PSVD (ROC analysis)
Differences among PSVD and cirrhosis in perfusion parameters will be analyzed in order to identify the cut-offs with the best sensitivity and specificity to identify PSVD from DCE-US.
Measured: Baseline
Performance of a multiparametric diagnostic score combining DCE-US parameters, liver stiffness, spleen stiffness, and B-mode ultrasound features
The mentioned cut-offs in DCE-US parameters will be combined with the bidimensional ultrasound data, Doppler data and elastography data to elaborate a noninvasive diagnostic score to predict the presence of PSVD
Measured: Baseline
Correlation between quantitative DCE-US parameters and risk of portal vein thrombosis at 12 months.
DCE-US parameters will be correlated with the incidence of portal vein thrombosis in order to detect if these parameters may be predictive of developing this condition, potentially allowing to identify the cohort of patients who would benefit more from prophylactic anticoagulation
Measured: from enrollement to 12 months
Incidence of portal vein thrombosis at 12 months
The proportion of patients developing porta vein thrombosis at 12 months
Measured: From baseline to 12 months
Incidence of disease-related complications (ascites decompensation, hepatic encephalopathy, variceal bleeding) at 12 months in both arms
Nunmber of portal hypertension-related complications per patient in both arms from the enrollement to 12 months
Measured: From enrollement to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porto-sinusoidal Vascular Liver DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Assunta Zocco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492862
- Sponsor's protocol ID
- 8071
- Acronym
- CEUS-PSVD
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Study for the Application of Dynamic Contrast-enhanced Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
- ClinicalTrials.gov ID
- NCT07492862
- Acronym / sponsor ID
- CEUS-PSVD / 8071
- Conditions
- Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis, Portal Hypertension, Noncirrhotic, Portal Hypertension Related to Cirrhosis, Ultrasound Elastography, Contrast-enhanced Ultrasound
- Keywords
- porto-sinusoidal vascular liver disorder, liver cirrhosis, liver ultrasound, ultrasound elastography, dynamic contrast-enhanced ultrasound, chronic liver disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests.
Contrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes.
To date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSVD (Porto-Sinusoidal Vascular Disorder) | Experimental | Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox SoftwareParticipants with confirmed porto-sinusoidal vascular disease undergoing DCE-US with quantitative perfusion analysis using the VueBox software device |
| Cirrhosis | Experimental | Device: Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox SoftwareParticipants with confirmed liver cirrhosis undergoing DCE-US with quantitative perfusion analysis using the VueBox software device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox SoftwarePatients from the two arms will undergoing dynamic contrast-enhanced ultrasound, and CEUS videoclips will be analyzed through the software VueBox to evaluate perfusion parameters. These parameters will be compared among the two arms and integrated with other ultrasound-derived data to analyze differences and to elaborate a multiparametric diagnostic score | Device | Cirrhosis, PSVD (Porto-Sinusoidal Vascular Disorder) |
Primary outcome
Peak enhancement (PE) measured on DCE-US (VueBox)
Time frame: Baseline
Maximum intensity of the signal in the time-intensity curve at dynamic contrast-enhanced ultrasound
Time to peak (TTP) measured on DCE-US (VueBox)
Time frame: Baseline
The time required from the beginning of the exam to reach the peak enhancement
Area under the time-intensity curve (AUC) measured on DCE-US (VueBox)
Time frame: Baseline
The total area under the time-intensity curve reflecting the quantity of contrast media passed through the region of interest
Wash-in rate (slope) measured on DCE-US (VueBox)
Time frame: Baseline
Tangent at the ascending part of the time-intensity curve
Mean Transit Time measured on DCE-US (VueBox)
Time frame: Baseline
Mean time taken by contrast to pass through the ROI
Rise Time measured on DCE-US (VueBox)
Time frame: Baseline
Time from peak enhancement to point where tangent of ascending curve across x-axis
Wash-out rate measured on DCE-US (VueBox)
Time frame: Baseline
The tangent at the descending part of the time-intensity curve
5 secondary outcomes
Diagnostic sensitivity and specificity of predefined perfusion parameter cut-offs for identifying PSVD (ROC analysis)
Time frame: Baseline
Performance of a multiparametric diagnostic score combining DCE-US parameters, liver stiffness, spleen stiffness, and B-mode ultrasound features
Time frame: Baseline
Correlation between quantitative DCE-US parameters and risk of portal vein thrombosis at 12 months.
Time frame: from enrollement to 12 months
Incidence of portal vein thrombosis at 12 months
Time frame: From baseline to 12 months
Incidence of disease-related complications (ascites decompensation, hepatic encephalopathy, variceal bleeding) at 12 months in both arms
Time frame: From enrollement to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Assunta Zocco contact
mariaassunta.zocco@policlinicogemelli.it; raffaele.borriello@unicatt.it
Maria Assunta Zocco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software in people with Porto-sinusoidal Vascular Liver Disorder and Liver Cirrhosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Assunta Zocco (+39 0630155057, mariaassunta.zocco@policlinicogemelli.it; raffaele.borriello@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak enhancement (PE) measured on DCE-US (VueBox) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.