| CTRI Number |
CTRI/2024/01/061591 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of role of MRI in O-RADS classification system |
|
Scientific Title of Study
|
TO PREDICT THE ACCURACY AND VALIDITY OF O-RADS MRI SCORING SYSTEM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddharth Suri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Radiodiagnosis, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
Udupi
KARNATAKA
576104
India |
| Phone |
7624845610 |
| Fax |
|
| Email |
siddsuri610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakashini K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Radiodiagnosis, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845053325 |
| Fax |
|
| Email |
prakashini.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prakashini K |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
Department of Radiodiagnosis, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
KARNATAKA
576104
India |
| Phone |
9845053325 |
| Fax |
|
| Email |
prakashini.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Kasturba Medical College, Manipal
|
| 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 Siddharth Suri |
Kasturba Medical College |
Room no 3
Department of Radiodiagnosis and Imaging
Udupi
Udupi
KARNATAKA |
7624845610
siddsuri610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and kasturba hospital intstitutional ethics committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients with MRI for adnexal mass characterisation |
|
| ExclusionCriteria |
| Details |
Proven histopathological cases of metastasis to the ovary
Poor quality MRI
Age less than 18 years
Failure to acquire contrast or ADC sequence in the patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to test the performance of the Ovarian Adnexal reporting Data system MRI in characterising adnexal masses with cystic component |
31st JULY 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if there is any additional benefit of adding DW ADC to O-RADS MRI |
31st DECEMBER 2025 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
22/01/2024 |
| 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="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
|
The study will be conducted only after approval from the Institutional Ethics Committee Consent
will be taken from each patient before conduction of MRI Patients with suspected/known ovarian disease fulfilling the inclusion criteria will undergo MRI . After acquisition, images will be processed using
relevant software to calculate the assessment parameters. No additional charges are needed from the
patient apart from standard hospital MRI charges. There is no exposure to any radiation. The
study follows the standard imaging and treatment protocols and will cause no harm to the patient
knowingly |