NCT07440511 Spleen Stiffness Measurement for the Detection of Advanced Fibrosis
| NCT ID | NCT07440511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-01-28 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Measurement of spleen stiffness (SSM) has shown potential as a complementary tool to liver stiffness measurement (LSM) for the assessment of portal hypertension in patients with MASLD, particularly in the setting of compensated advanced chronic liver disease (cACLD). The 100-Hz probe for SSM, developed more recently, improves the accuracy of spleen stiffness measurements by better capturing the specific characteristics of the splenic parenchyma. This method has been shown to correlate well with HVPG, the gold standard for the assessment of portal hypertension, and has demonstrated good predictive value for the detection of high-risk varices, which are indicative of advanced liver disease. The correlation between SSM and other clinical markers, such as spleen size and platelet count, has proven to be strong, further supporting its utility in assessing disease progression. This makes SSM a promising non-invasive tool for early detection and risk stratification in MASLD, which is crucial for preventing progression to more severe stages such as cirrhosis or hepatocellular carcinoma. In conclusion, the combined use of LSM and SSM shows great potential for improving the non-invasive diagnosis and monitoring of MASLD, providing an efficient alternative to more invasive methods such as liver biopsy and HVPG. This evidence has led to the inclusion of SSM use in clinical guidelines for the management of patients with chronic liver disease. Nevertheless, further studies are needed to confirm these findings and to refine clinical protocols, potentially allowing earlier intervention and improved management of patients with MASLD and its complications.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Diagnosis of MASLD according to EASL guidelines * Presence of cACLD confirmed by histology (fibrosis F3-F4) or assessed non-invasively (LSM \> 15 kPa), OR suspected cACLD based on non-invasive tests (LSM \> 8 kPa) that leads to or has led to the indication for liver biopsy according to routine clinical practice * Signed informed consent for the prospective cohort Exclusion Criteria: * Other etiologies of liver disease, including viral, autoimmune/cholestatic, drug-induced, alcohol-related liver disease (ALD), or use of hepatotoxic drugs (e.g. long-term oral corticosteroids, estrogen-progestin therapy, methotrexate, valproic acid) * Primary or secondary liver cancer * Previous hepatic decompensation * Hematological disorders * Portal vein thrombosis * Previous TIPS placement * Previous liver transplantation * Current or past extrahepatic malignancy (\< 5 years) * Previous bariatric surgery (\< 3 years)
Contact & Investigator
Luca Miele
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07440511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07440511 currently recruiting?
Yes, NCT07440511 is actively recruiting participants. Contact the research team at luca.miele@policlinicogemelli.it for enrollment information.
Where is the NCT07440511 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07440511 clinical trial?
NCT07440511 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Luca Miele at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 500 participants.