Endoscopic Ultrasound Shear Wave Elastography Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Olympus Corporation of the Americas
Study ID
NCT06592820
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Liver Disease
  • Fibrosis, Liver
  • MASH
  • MASLD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging — DEVICE
    EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).
  • FibroScan — DEVICE
    A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.
  • Liver biopsy — DEVICE
    A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically. Endoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.

Study Details

This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\[s\] it aims to answer are: * Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis * Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores). Participants will undergo: * Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI) * Liver biopsy * FibroScan

Key Dates

Start date
Sep 3, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2027
Completion
Mar 28, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: All subjects enrolled
    Consecutive, eligible patients reporting for an endoscopic ultrasound liver biopsy and FibroScan for evaluation of liver fibrosis will be enrolled. EUS-SWE/ATI will be compared to liver biopsy pathology results, FibroScan (VCTE and CAP) results, and screening scores).

Primary Outcome Measure

Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system [ Time Frame: During study data analysis ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele Ryan, MS
[email protected]
617-676-5928
Samantha Geltz
[email protected]
843-290-4268
Marvin Ryou, MD (PRINCIPAL_INVESTIGATOR)
Geisinger Medical CenterDanvillePennsylvania17822
Kali Rebuck
[email protected]
570-214-1186
Nikolas Antinnes
[email protected]
5702141186
Khara Harshit, MD (PRINCIPAL_INVESTIGATOR)

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Brigham and Women's Hospital· Boston, MAGeisinger Medical Center· Danville, PA

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