| CTRI Number |
CTRI/2025/08/093668 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Choline Levels in Cancer Patients of Gall-Bladder Upon Using Radiological Imaging Modalities (MR Spectroscopy) |
|
Scientific Title of Study
|
Evaluation of choline levels in gall bladder carcinoma using magnetic resonance spectroscopy. |
| 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 Anjali Kumari |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College(Datta meghe institute of higher education and research) |
| Address |
Department of Radio-diagnosis, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8550988657 |
| Fax |
|
| Email |
anjalikr7878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav V Mishra |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College(Datta meghe institute of higher education and research) |
| Address |
Department of Radio-diagnosis, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
gaurav.mishra@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav V Mishra |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College(Datta meghe institute of higher education and research) |
| Address |
Department of Radio-diagnosis, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
gaurav.mishra@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of higher education and research,Sawangi,Wardha,India ,442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College Datta Meghe Institute Of higher education and research |
| Address |
Department Of Radio-Diagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, 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 Anjali Kumari |
Datta Meghe Institute Of Higher Education and Research |
MRI Imaging Room,Division of MRI Imaging, Department Of Radio-Diagnosis Acharya Vinoba Bhave Rural Hospital Sawangi
Wardha
MAHARASHTRA |
8550988657
anjalikr7878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiological Voxel on MRI |
A voxel is a measurement of volume in a structure that is to be imaged. Each voxel represents a defined volume, and can be localized by coordinates on a three-dimensional grid. Both CT and MRI scanners image a slab of tissue and describe it in a two-dimensional image on the computer screen. Each image is made up of a matrix of two-dimensional cells called pixels. Each pixel represents a volume of tissue, or voxel. The voxel has the same 2-D (x-axis, y-axis) size as the pixel, but the third dimension (z-axis) is equivalent to the slice thickness of the scan.
To Evaluate Choline Levels in Carcinoma Gall Bladder a Radiological Voxel is placed at the site of Carcinoma before performing MR Spectroscopy. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)To study the spectrum of MRI findings in gall bladder carcinoma.
2)To determine the choline levels under MR Spectroscopy in gall bladder carcinoma.
|
|
| ExclusionCriteria |
| Details |
1. A patient who had surgery or medical care
in the past.
2. Women who are pregnant.
3. Patients with pacemakers, cochlear implants, or
metallic implants.
4. Patients with any type of psychological
condition including claustrophobia.
5. Patients who are unwilling or uncooperative.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establish the co-relation between choline levels peak and likelihood of metastasis of Ca Gallbladder at the site of Choline Peak with the help of MR Spectroscopy. |
All patients will be assessed at the end of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the potential of MR spectroscopy in detecting choline levels as a biomarker for gall bladder carcinoma. |
All patients will be assessed at the end of 3 months. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/09/2025 |
| 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="0"
Months="3"
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
|
Gallbladder carcinoma is a relatively rare but highly aggressive malignancy of the biliary tract with poor prognosis mainly due to its often late diagnosis and limited treatment options. Early detection and accurate staging of GBC are crucial for improving patient outcome. MRI have shown promise in enhancing accuracy and prognostic values in GB carcinoma patients. MRS enables the non-invasive assessment of metabolites levels within tissues offering insights into cellular metabolites and providing biomarkers for cancer detection and characterization. One such metabolite of interest is choline, a component of cell membrane whose elevation levels has been associated with increased cell proliferation and malignant transformation. Therefore this study will aim to investigate the role of MRI and MR spectroscopy in evaluating choline levels in GB carcinoma patients to improve early detection and guide personalized treatment for this aggressive malignancy. |