| CTRI Number |
CTRI/2024/05/067701 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding spinal cord diseases using MRI |
|
Scientific Title of Study
|
Role of magnetic resonance spectroscopy in spinal cord lesions with clinical and / or histopathological correlation |
| 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 Saraswathula L G V R Bharadwaj |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radio-diagnosis,
Ground Floor , A.V.B.R.H building,
Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8712238243 |
| Fax |
|
| Email |
slgvrbharadwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirish V Vaidya |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Radio-diagnosis,
Ground Floor, A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7038555648 |
| Fax |
|
| Email |
drshirish283@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirish V Vaidya |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Radio-diagnosis,
Ground floor , A.V.B.R.H building,
Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7038555648 |
| Fax |
|
| Email |
drshirish283@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi, Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Sawangi, Wardha 442001, Maharashtra |
| 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 Saraswathula L G V R Bharadwaj |
Datta Meghe Institute of Higher Education and Research |
Department of Radio-diagnosis,
Ground floor , A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA |
8712238243
slgvrbharadwaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G950||Syringomyelia and syringobulbia, (2) ICD-10 Condition: G951||Vascular myelopathies, (3) ICD-10 Condition: G952||Other and unspecified cord compression, (4) ICD-10 Condition: G958||Other specified diseases of spinalcord, (5) ICD-10 Condition: G959||Disease of spinal cord, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients with spinal cord lesions on M.R. imaging |
|
| ExclusionCriteria |
| Details |
Patients with metal implants or foreign bodies in their eyes, pacemakers,
Claustrophobic patients,
Uncooperative and non-consenting patient.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant correlation between findings of MR spectroscopy and clinical or histopathological findings of spinal cord lesions. |
Assessment will be done at the end of 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/07/2024 |
| 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="2"
Months="6"
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
|
INTRODUCTION The spinal cord contains a variety of lesions, both non-neoplastic and neoplastic. Magnetic resonance spectroscopy (M.R.S.) is a non-invasive method for analyzing the chemical composition of human tissue. As a result, it contributes to a better understanding of pathological conditions affecting the spinal cord and provides important biomarkers for diagnostic purposes. Magnetic Resonance spectroscopy provides insights into cellular composition, tissue integrity, and metabolic activity through the analysis of metabolite levels, guiding differential diagnosis and therapeutic decisions. Correlating M.R.S. findings to clinical presentation and histopathological analysis improves diagnostic accuracy and informs prognosis. A.I.M. To assess spinal cord lesions using M.R.S. (magnetic resonance spectroscopy) and correlate the results clinically and/or histo-pathologically. OBJECTIVES 1. To evaluate the spectrum of spinal cord lesions using magnetic resonance imaging. 2. To ascertain the magnitude of peaks of various metabolites in patients with intramedullary and extramedullary spinal cord lesions using magnetic resonance spectroscopy sequences. 3. To correlate the interpreted magnetic resonance spectroscopy findings clinically or histo-pathologically. METHODS The study involves a sample of 33 patients. It employs a prospective cross-sectional approach who come to A.V.B.R.H. associated with Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, in the interval of December 2023 and December 2025. Magnetic resonance spectroscopy will be done in patients with spinal cord lesions under the inclusion criteria. Using statistical methods, M.R.S.’s role as an adjunct diagnosis tool will be found. OUTCOME MEASURES The outcome will demonstrate the practical impact of Magnetic Resonance Spectroscopy, which, when combined with clinical and histopathological information, can help in the accurate diagnosis of spinal cord lesions. |