| CTRI Number |
CTRI/2025/04/085125 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnostic Accuracy of Limited Sequences of MRI Brain vs
Full Protocol in New Onset of Neurological Complaint |
|
Scientific Title of Study
|
Observational comparative study of diagnosis made from MRI brain full protocol study and limited sequence study in patient with neurological complains. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyesh A. Patel |
| Designation |
Resident Doctor |
| Affiliation |
Sir T Hospital |
| Address |
Department of Radiodiagnosis, Government Medical College, Sir Takhtasinhji General Hospital, PMSSY Building, Bhavnagar. 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9638095479 |
| Fax |
|
| Email |
idivyesh18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divyesh A. Patel |
| Designation |
Resident Doctor |
| Affiliation |
Sir T Hospital |
| Address |
Department of Radiodiagnosis, Government Medical College, Sir Takhtasinhji General Hospital, PMSSY Building, BHAVNAGAR. 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9638095479 |
| Fax |
|
| Email |
idivyesh18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vipul V. Solanki |
| Designation |
Associate Professor |
| Affiliation |
Sir T Hospital |
| Address |
Department of Radiodiagnosis, Government Medical college, Sir Takhtasinhji General Hospital, PMSSY Building, Bhavnagar. 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9016910257 |
| Fax |
|
| Email |
virbapu1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Radiodiagnosis, Sir Takhtasinhji General Hospital, PMSSY Building, Bhavnagar. 364001 |
|
|
Primary Sponsor
|
| Name |
Divyesh A PATEL |
| Address |
Department Of Radiodiagnosis, Government Medical College, Sir Takhtasinhji General Hospital, PMSSY Building, Bhavnagar, 364001 |
| 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 Divyesh A Patel |
Sir Takhtasinhji General Hospital, PMSSY and Sahyog MRI Center Government Medical College Bhavnagar |
Room No-6, Department of Radiodiagnosis, Sir Takhatasinhji General Hospital, Bhavnagar, 364001
Bhavnagar
GUJARAT |
9638095479
idivyesh18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of age and gender, with New Onset Neurological Complaint Less than 1 week in which MRI Brain scan full protocol done, report and request form available for retrieval. |
|
| ExclusionCriteria |
| Details |
Specialized MR protocols (e.g. pituitary, orbits, and internal auditory canal studies).
Full Protocol scan with normal reports and no findings
Patient with history of trauma and traumatic intra cranial haemorrhage.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether or not a MRI BRAIN limited sequences should be incorporated in patient with new onset neurological complaint. |
21 MONTHS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
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)
|
28/04/2025 |
| 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="9"
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
|
MRI Brain
is one of the most commonly performed techniques of medical imaging. It
enables clinicians to focus on various parts of the brain and examine their anatomy and
pathology, using different MRI sequences, such as T1W, T2W, or FLAIR in
patients with new onset focal neurological complaint. The
biggest advantage of MRI is that it is radiation free. However, it has long scan
time as compared to CT which makes CT brain as a primary imaging modality for
urgent neurological conditions. However,
a limited sequences MRI with T1-weighted, T2-weighted, and diffusion-weighted
images (with apparent diffusion coefficient mapping), can be acquired in short
time – as fast as 3-4 minutes. Such a limited sequence MRI brain would yield better results than a CT,
and a further MRI with long sequence protocol can be avoided. So,
in Routine practice has an increasing clinical need to reduce the scan time of
brain MRI by using limited sequences, especially for motion-prone patients or
patients with time-critical diseases. |