Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04985188
Other study ID # 2102-159-1199
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 12, 2021
Est. completion date December 31, 2022

Study information

Verified date July 2021
Source Seoul National University Hospital
Contact Jeong Min Lee, MD
Phone 02-2072-3107
Email jmlshy2000@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD) - Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation - aged = 18 years who are willing and able to complete all procedures Exclusion Criteria: - excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women) - clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders - use of steatogenic or hepatotoxic medication - evidence of decompensated liver disease - history of liver surgery - any other condition believed by investigator to affect a patients' compliance, or completion of the study

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Quantitative ultrasound (QUS) technique
Measurement of quantitative ultrasound parameter using clinical US machine (RS85)

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Seoul National University Hospital First Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, Samsung Medison, Shenzhen Second People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1) Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result) 1 month
Secondary Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3) Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result) 1 month
Secondary Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH) Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result) 1 month
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT03073746 - Google Health Search Trial N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Completed NCT04168983 - Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy N/A
Recruiting NCT05194527 - The Detrimental Course of Acute Intestinal Ischemia
Not yet recruiting NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Recruiting NCT05043662 - UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Recruiting NCT04056273 - Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate N/A
Completed NCT03193671 - Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis N/A
Recruiting NCT03210311 - Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema N/A
Completed NCT04299412 - Diagnostic Accuracy of the DPP II Assay
Active, not recruiting NCT05185388 - Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017
Completed NCT04212286 - Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC N/A
Completed NCT04109625 - Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening N/A
Not yet recruiting NCT05064566 - Evaluation of Caries Detection Methods
Recruiting NCT03347630 - Pre-operative MRI of Esophagus Cancer N/A
Completed NCT05604482 - CXCR4-PET/CT for Diagnosing Giant Cell Arteritis N/A
Completed NCT04541160 - Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
Completed NCT04315207 - Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis N/A