| CTRI Number |
CTRI/2026/02/103535 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
MRI of the liver to measure iron overload in patient with long term liver and blood disorders. |
|
Scientific Title of Study
|
To evaluate the role of MRI liver in assessing hepatic iron overload in patient with systemic and chronic liver disease. |
| 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. Shrishty Agrawal |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9009489818 |
| Fax |
|
| Email |
shrishtyagrawal1711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratap Singh Parihar |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Radiodiagnois, Ground Floor, AVBRH Building , Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422104957 |
| Fax |
|
| Email |
drphparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shrishty Agrawal |
| Designation |
postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9009489818 |
| Fax |
|
| Email |
shrishtyagrawal1711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe , Wardha , India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe , Wardha , India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Shrishty Agrawal |
Acharya Vinoba Bhave Rural Hospital |
Dept of Radiodiagnosis , Ground floor , AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA |
9009489818
shrishtyagrawal1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research,Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any age and gender with clinical suspicion or diagnosis of hepatic iron overload.
2.Patients diagnosed with systemic and chronic liver diseases
3.Willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to MRI (e.g., pacemakers, metallic implants).
2.Pregnant patients.
3.Patients with severe claustrophobia or inability to cooperate.
4.Patients who refuse to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Usefulness of MRI as a reliable and non-invasive method for evaluating liver iron levels. |
Assessment will be done at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1To evaluate MRI characteristic of liver parenchyma on different MRI sequence and to identify and place Region of interest (ROI) within the liver parenchyma, avoiding vessels and artefacts |
1 YEAR 8 MONTH |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study evaluates the utility of MRI in detecting and quantifying hepatic iron overload in patients with systemic and chronic liver diseases. In regions like Wardha in central India, where conditions such as Sickle Cell Anaemia and cirrhosis are prevalent, MRI offers a non-invasive, accurate alternative to liver biopsy. The study establishes MRI as a valuable tool for early diagnosis, monitoring, and guiding treatment decisions in high-risk populations |