| CTRI Number |
CTRI/2025/09/095010 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Cross Sectional |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ASL MRI in epilepsy |
|
Scientific Title of Study
|
Role of ASL non contrast perfusion MRI in evaluation of patients with epilepsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaurya Khanduri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Radiodiagnosis and Imaging, Kasturba Hospital, Kasturba Medical College, Madhav Nagar, Eshwar Nagar, Manipal, Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
7022889424 |
| Fax |
|
| Email |
shauryakhanduri97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Venugopal |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
Department of Radiodiagnosis and Imaging, KMC Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845085668 |
| Fax |
|
| Email |
anandvmanipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anand Venugopal |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
Department of Radiodiagnosis and Imaging, KMC Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845085668 |
| Fax |
|
| Email |
anandvmanipal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Kasturba Medical college, Manipal Academy of Higher Education, Manipal - 576104, UDUPI DISTRICT, KARNATAKA, INDIA. |
|
|
Primary Sponsor
|
| Name |
Shaurya Khanduri |
| Address |
Department of Radiodiagnosis and Imaging, Kasturba Hospital and Kasturba Medical college, Manipal Academy of Higher Education, Manipal - 576104, Udupi District, Karnataka, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Shaurya Khanduri |
Department of Radiodiagnosis and Imaging |
DDepartment of Radiodiagnosis and Imaging, Udupi - Hebri Rd, Madhav Nagar, Manipal,
Udupi
KARNATAKA |
7022889424
shauryakhanduri97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA HOSPITAL , KASTURBA MEDICAL CLLOEGE MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with suspected or diagnosed epilepsy who have undergone or will undergo EEG monitoring and have been referred for Brain MR imaging.
|
|
| ExclusionCriteria |
| Details |
General contraindications to MR neuro-imaging such as cardiac pacemakers, implantable defibrillators.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri-ictal /interictal perfusion changes and their localisation - Hyperperfusion/Hypoperfusion |
AT baseline. Immediately after acquisition and post processing of ASL-MRI sequence is complete. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Agreement between ASL sMRI & EEG seizure zone localisation. |
Once patient undergoes the above mentioned investigations MRI ASL & EEG. Usually on the same day. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
27/09/2025 |
| 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="1"
Months="0"
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
|
Consecutive patients with neocortical epilepsy who have undergone EEG monitoring and are referred to the Department of Radiodiagnosis and Imaging to undergo MRI imaging according to the standard epilepsy protocol will be included.
A single post labelling delay (PLD) pseudocontinuous-ASL (PCASL) sequence will be included in the MRI studies – generating CBF maps in grayscale and colour. Areas of altered perfusion on ASL will be identified. Using manually drawn region of interests asymmetry indices will be calculated.
Regional cerebral blood flow maps will be compared with the EZ determined by the other tests and the strength of concordance will be assessed using Kappa coefficient.
|