| CTRI Number |
CTRI/2025/07/090059 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Noninterventional |
| Study Design |
Other |
|
Public Title of Study
|
A non-interventional study in participants (patients) with confirmed fibrosis in chronic liver disease (as a regular diagnosis process by physician) to develop advanced Magnetic Resonance Imaging (MRI) Based Biomarker models for Detecting Fibrosis and Classifying Fibrosis Stage in Adults. |
|
Scientific Title of Study
|
Development of a Magnetic Resonance Imaging (MRI) Based Biomarker for Detecting Fibrosis and Classifying Fibrosis Stage in Adults with Biopsy Proven Chronic Liver Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NMRR-19-3498-51635 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagaraj Vayyavuru |
| Designation |
Project Manager |
| Affiliation |
Vichag Limited |
| Address |
#49, 47th Street, Ashok Nagar, Chennai
Chennai
TAMIL NADU
600083
India |
| Phone |
8147496004 |
| Fax |
|
| Email |
smileynagaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nagaraj Vayyavuru |
| Designation |
Project Manager |
| Affiliation |
Vichag Limited |
| Address |
#49, 47th Street, Ashok Nagar, Chennai
Chennai
TAMIL NADU
600083
India |
| Phone |
8147496004 |
| Fax |
|
| Email |
smileynagaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagaraj Vayyavuru |
| Designation |
Project Manager |
| Affiliation |
Vichag Limited |
| Address |
#49, 47th Street, Ashok Nagar, Chennai
Chennai
TAMIL NADU
600083
India |
| Phone |
8147496004 |
| Fax |
|
| Email |
smileynagaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Resonance Health |
| Address |
PO Box 108 Victoria Park, Western Australia, 6979 AUSTRALIA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Malaysia |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pathik Parikh |
Reliver Clinic |
701, Santorini Square, Behind Abhishree Complex, Lane Opp Star bazar, Jodhpur
Ahmadabad
GUJARAT |
9825347478
pathik269@gmail.com |
| Dr Tom Cherian |
South Asian Liver Institute |
Tenet Diagnostics, 8-2-269/4/B, Road No 2, Banjara Hills, Hyderabad
Hyderabad
TELANGANA |
9573670670
drtomsali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
| MAARG Independent Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Known diagnosis of chronic liver disease |
|
| ExclusionCriteria |
| Details |
Inadequate biopsy length for histology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relationship between liver fibrosis assessment using analysed Magnetic Resonance Imaging (MRI) parameters for detection and staging of liver fibrosis |
Within 183 days of confirmed fibrosis in CLD patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine thresholds optimising the sensitivity of Liver Fibrosis-MRI to screen patients & optimising specificity to confirm liver fibrosis stage |
Within 183 days of confirmed fibrosis in CLD patients. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/03/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
There is an unmet need for novel, more accurate non-invasive techniques including imaging based techniques in order to improve fibrosis assessment and patient outcomes. Development of such biomarkers has been highlighted by the FDA and other regulators as a critical requirement to accelerate drug development for the treatment of NASH NAFLD MAFLD.An accurate non invasive predictive method for assessing liver fibrosis has appeal and will gain more acceptance among patients and clinicians for disease staging, determine prognosis, guiding treatment strategies, and provides standards for inclusion and end points assessment in clinical trials to avoid unnecessary liver biopsies. To meet this unmet need, this study aims to develop predictive models of liver fibrosis based on MRI data analysis outcomes using liver biopsy as the reference standard. |