| CTRI Number |
CTRI/2025/08/093632 [Registered on: 25/08/2025] 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
|
Prospective Cross Sectional Study Of Role Of MRI in Evaluation Of Solid Supratentorial Neoplasms In Adult And Pediatric Population. |
|
Scientific Title of Study
|
Role Of MRI in Evaluation Of Solid Supratentorial Neoplasms In Adult And Pediatric Population. |
| 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 Paritosh Bhangale |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001.
Wardha MAHARASHTRA 442001 India |
| Phone |
9967647919 |
| Fax |
|
| Email |
paritosh.bhangale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001.
Wardha MAHARASHTRA 442001 India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001.
Wardha MAHARASHTRA 442001 India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, DEPARTMENT OF RADIODIAGNOSIS,SAWANGI, WARDHA, MAHARASHTRA, INDIA 442001. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Datta Meghe Institute Of Higher Education And Research, Department Of radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe Institute Of Higher Education And Research |
Datta Meghe Institute Of Higher Education And Research, Department Of radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paritosh Bhangale |
Datta Meghe Institute Of Higher Education And Research |
Datta Meghe Institute Of Higher Education And Research, Department Of Radiodiagnosis, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra - 442001. Wardha MAHARASHTRA |
9967647919
paritosh.bhangale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All solid lesions in the supratentorium region of brain detected on MR studies will be taken.
2.All age groups irrespective of sex will be included.
|
|
| ExclusionCriteria |
| Details |
1.Patient having history of cardiac pacemakers, metallic implants insertion, and metallic foreign body in situ.
2.Patient having history of claustrophobia.
3.Supratentorial pathology due to infections,trauma or cerebrovascular accidents will be excluded.
4.Pregnant Patients.
5.Uncooperative patients and patients not giving informed consent.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the characteristics, distribution, and localization of the extent of supratentorial tumors by MRI. |
4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the role of Conventional MRI,DWI,MR spectroscopy in the evaluation of solid supratentorial tumors. |
4 Months |
|
|
Target Sample Size
|
Total Sample Size="59" Sample Size from India="59"
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="2" Months="0" 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
|
Brain tumors can be categorized as supratentorial, midline or infratentorial tumors based on their location. The use of MR imaging has been widely recognized as the most effective screening technique for detecting intracranial tumors. By utilizing pulse sequences, MRI imaging generates higher contrast resolution between adjacent brain parenchyma and structural irregularities. The administration of paramagnetic contrast agents further enhances MRI’s ability to detect focal lesions of the brain, making it a more sensitive diagnostic tool. In this research study, we analyze the magnetic resonance imaging characteristics of diverse solid neoplasms located above the tentorium cerebelli. |