| CTRI Number |
CTRI/2025/01/079755 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
differences between endometrium lesions in the uterus using MRI imaging Techniques |
|
Scientific Title of Study
|
Optimization and efficiency of hybrid Intravoxel incoherent motion and diffusion kurtosis imaging in differentiating benign and malignant endometrial lesions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha R |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09886358906 |
| Fax |
|
| Email |
varsha.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Medical Hospital, Manipal, Karnataka, Pin-576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE, Manipal, Karnataka Pin-576104 |
| Type of Sponsor |
Research institution |
|
|
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 Rajagopal KV |
Kasturba Hospital |
Main MRI room, Ground floor , Near emergency block Department of Radiodiagnosis and Imaging, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C578||Malignant neoplasm of overlappingsites of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Phase 1
patients referred for MRI pelvis with no endometrial abnormalities.
Phase 2
Patients referred for MRI Pelvis with endometrial lesions. |
|
| ExclusionCriteria |
| Details |
Phase 1 and Phase 2
Patients who are contraindicated for MRI and pre-operated for any abnormality in the uterus or endometrium.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase 1
IVIM and DKI parameters
Phase 2
differentiation of benign and malignant endometrial lesions from IVIM DKI parameters |
soon after the scan IVIM-DKI parameters will be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between ADC and IVIM DKI parameters. |
At the time of the scan |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2025 |
| 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="3"
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
|
This study aims to optimize and evaluate the diagnostic accuracy of IVIM AND DKI MRI imaging in differentiating benign and malignant endometrial lesions. Phase 1: Focuses on the optimization of the b-values for imaging of the pelvis for normal endometrium and myometrium in non-affected females. Phase 2: Differentiation of benign and malignant endometrial lesions will be done by the obtained IVIM-DKI parametric numerical values. |