RECRUITING

Endoscopic Ultrasound Shear Wave Elastography Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease

Quick Facts

Study Start:2025-09-03
Study Completion:2027-03-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06592820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 2. Willing and able to provide informed consent
  3. 3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
  4. 4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
  5. 5. BMI \>/=28
  6. 6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)
  1. 1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
  2. 2. Prior history of Hepatitis B or C infection
  3. 3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
  4. 4. Histological evidence of other concomitant chronic liver disease on biopsy
  5. 5. Inadequate liver biopsy
  6. 6. Prior history of or current excess alcohol consumption (\>140 g/week and \>210 g/week for females and males, respectively) documented in EMR

Contacts and Locations

Study Contact

Octavia Plingu
CONTACT
4089413623
octavia.plingu@olympus.com
Jewel Gill
CONTACT
9196333967
Jewel.Gill@olympus.com

Principal Investigator

Marvin Ryou, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Boston, MA

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States

Collaborators and Investigators

Sponsor: Olympus Corporation of the Americas

  • Marvin Ryou, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital, Boston, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03
Study Completion Date2027-03-28

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2027-03-28

Terms related to this study

Keywords Provided by Researchers

  • Shear Wave Elastography
  • Shear Wave
  • FibroScan
  • Attenuation Imaging

Additional Relevant MeSH Terms

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