| CTRI Number |
CTRI/2024/08/072422 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Prospective quantitative evaluation of the fatty liver using ultrasound parameters |
|
Scientific Title of Study
|
Diagnostic performance of quantitative ultrasound parameters in
assessing hepatic steatosis in NAFLD with MRI PDFF as the reference standard a prospective non randomized cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Rajendra Agarwal |
| Designation |
Principal Consultant |
| Affiliation |
Max Smart Super speciality Hospital |
| Address |
Max Smart Super Speciality hospital Saket Complex Ground Floor Department of Radiology room no 1 office Area 1 Press Enclave Marg Saket New Delhi 110017
South
DELHI
110017
India |
| Phone |
9871575393 |
| Fax |
|
| Email |
Abhishek.Agarwal@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Rajendra Agarwal |
| Designation |
Principal Consultant |
| Affiliation |
Max Smart Super speciality Hospital |
| Address |
Max Smart Super Speciality hospital Saket Complex Ground Floor Department of Radiology room no 1 office Area 1 Press Enclave Marg Saket New Delhi 110017
South
DELHI
110017
India |
| Phone |
9871575393 |
| Fax |
|
| Email |
Abhishek.Agarwal@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Arora |
| Designation |
Clinical Researcher |
| Affiliation |
Max Super speciality Hospital |
| Address |
Max Super Speciality hospital Saket Complex West Block Ground Floor Department of Radiology room no 5 office Area 1 Press Enclave Marg Saket New Delhi 110017
South
DELHI
110017
India |
| Phone |
9760273996 |
| Fax |
|
| Email |
Muskan.Arora@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Samsung Medison Co Ltd
1077 Cheonho daero Gangdong gu Seoul Korea |
|
|
Primary Sponsor
|
| Name |
Samsung Medison Co.Ltd |
| Address |
1077 Cheonho-daero Gangdong-gu Seoul Korea |
| Type of Sponsor |
Other [Med Tech Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Kumar Sahu |
Max Smart Super Speciality Hospital |
Max Smart Superciality Hospital Ground Floor Department of radiology Room No 1 office area 1 Press Enclave Road Saket New Delhi 110017
South
DELHI |
7428304988
Amit.sahu@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound report and MRI report are the comparator |
The findings on the ultrasound parameters would be compared by that of MRI findings. The ultrasound procedure time is 15 mins and MRI procedure time is 30 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who clinically suspected MASLD based on EASL–EASD–EASO Clinical Practice
Guidelines for the management of Metabolic Dysfunction-Associated Steatotic Liver Disease
(MASLD), or patients who recommended to undergo either abdominal ultrasound
examination or liver MRI examination
2. Male or Female of Age ≥18 years ,
3. Individuals who have decided to participate in the clinical study on their own will and have
provided the informed consent after reading/hearing and fully understanding the detailed explanations regarding the clinical study. |
|
| ExclusionCriteria |
| Details |
1. Subject who has disagreed the signing of informed consent form for this study
2. Subject who has a history of chronic liver disease due to etiology other than MASLD.
3. Subject who had a daily alcohol consumption ⩾30 g for men and ⩾20 g for women based on
EASL– ASD–EASO Clinical Practice Guidelines for the management of metabolic dysfunctionassociated steatotic liver disease (MASLD)
4. Subject who has a history of long-term use of hepatotoxic drugs.
5. Subject with acute liver failure
6. Subject who has a history of esophageal varix, hydrops abdominis, hepatic coma, as well as
patents with signs of acute biliary obstruction, or those who had recent liver surgery.
7. Woman who is pregnant |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the diagnostic accuracy of TAI, TSI and US Fat fraction to predict different grades of hepatic steatosis in comparison with MRI-PDFF;S2 and S3 |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensitivity, Specificity, Positive predictive value (PPV), Negative Predictive Value (NPV) and
accuracy of quantitative ultrasound imaging parameters according to hepatic steatosis grade
(S2, S3)
ï‚· Optimal cut-off value of each of the three parameters in predicting non-alcoholic fatty liver
according to hepatic steatosis grade (S2, S3) for patients with suspected non-alcoholic fatty
liver
ï‚· The correlation between USFF and MRI-PDFF for assessing hepatic steatosis
ï‚· The correlation between TAITM and MRI-PDFF for assessing hepatic steatosis.
ï‚· The difference of diagnostic performance of USFF in compared to the subject assessment of
B-mode in each steatosis grade
ï‚· Bias, defined as the average difference between MRI-PDFF and USFF measurements per
participant |
1 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This clinical trial evaluates the diagnostic accuracy of ultrasound techniques and features, including Total Attenuation Imaging (TAIâ„¢), Tissue Scatter Imaging (TSIâ„¢), and Ultrasound Fat Fraction (USFF), for assessing hepatic steatosis compared to MRI Proton Density Fat Fraction (MRI-PDFF). Conducted at Max Smart Super Speciality Hospital, the study involves adults clinically suspected of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). It aims to correlate TAIâ„¢ and TSIâ„¢ with MRI-PDFF, compare USFF with B-mode ultrasound for different steatosis grades, and evaluate the relationship between USFF and clinical tests. Patients are recruited based on specific inclusion and exclusion criteria, with imaging performed on the same day as hospital appointments. Primary outcomes include the diagnostic performance of the ultrasound techniques, while secondary outcomes focus on sensitivity, specificity, and correlation with MRI-PDFF and clinical tests. The study strives to improve non-invasive diagnostic methods for hepatic steatosis. |