| CTRI Number |
CTRI/2025/09/095135 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ultrasound and MRI in the evaluation of endometriosis. |
|
Scientific Title of Study
|
Efficiency of ultrasonography compared to magnetic resonance imaging in the diagnosis of endometriosis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Jain |
| Designation |
First year radiology post graduate resident |
| Affiliation |
APOLLO KH HOSPITAL |
| Address |
Department of radiology,apollo kh hospital, melvisharam, ranipet vellore by pass road, ranipet dist,632509
Vellore
TAMIL NADU
632509
India |
| Phone |
8982950490 |
| Fax |
|
| Email |
drjainmonika18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PARANGAMA |
| Designation |
HEAD OF DEPARTMENT OF RADIOLOGY |
| Affiliation |
DEPARTMENT OF RADIOLOGY ,APOLLO KH HOSPITAL, MELVISHARAM, RANIPET VELLORE BY PASS ROAD, RANIPET DIST |
| Address |
Department of radiology,apollo kh hospital, melvisharam, ranipet vellore by pass road, ranipet dist,632509
Vellore
TAMIL NADU
632509
India |
| Phone |
9443309460 |
| Fax |
|
| Email |
parangamadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. PARANGAMA |
| Designation |
HEAD OF DEPARTMENT OF RADIOLOGY |
| Affiliation |
DEPARTMENT OF RADIOLOGY ,APOLLO KH HOSPITAL, MELVISHARAM, RANIPET VELLORE BY PASS ROAD, RANIPET DIST |
| Address |
Department of radiology,apollo kh hospital, melvisharam, ranipet vellore by pass road, ranipet dist,632509
Vellore
TAMIL NADU
632509
India |
| Phone |
9443309460 |
| Fax |
|
| Email |
parangamadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of radiology,apollo kh hospital, melvisharam, ranipet vellore by pass road, ranipet dist,632509
India |
|
|
Primary Sponsor
|
| Name |
APOLLO KH HOSPITAL |
| Address |
Department of radiology,apollo kh hospital, melvisharam, ranipet vellore by pass road, ranipet dist,632509 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Monika Jain |
APOLLO KH HOSPITAL |
ULRTASOUND ROOM AND MRI ROOM DEPARTMENT OF RADIOLOGY
Vellore
TAMIL NADU |
08982950490
drjainmonika18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHIHS Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80||Endometriosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are willing to take part in the study after written consent.
Patients presenting with symptoms suggestive of Endometriosis.
Incidental detected complex adnexal masses which are suspicious for endometriosis.
|
|
| ExclusionCriteria |
| Details |
Patients who refused the protocol and did not give consent.
Patients with other ovarian malignancies, who underwent Radiotherapy, chemotherapy.
Post- operative patient of endometriosis.
Pregnant females.
Patients with claustrophobia or any other absolute contraindication to MRI scanning (non-compatible metallic implants).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the diagnostic accuracy of ultrasonography with magnetic resonance imaging in patients of endometriosis.
|
BASELINE MRI
AFTER 1 HOUR TRANSVAGINAL ULTRASOUND AND THEN AFTER 1 HOUR DIAGNOSIS AND REPORTING. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of patient’s symptoms with imaging findings in Ultrasonography & MRI.
The various types of complications in patients with endometriosis.
|
60 minutes after investigations, correlation of patient’s symptoms with imaging findings in Ultrasonography & MRI.
60 minutes after investigations, the various types of complications in patients with endometriosis.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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="6"
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 main source of data is patients with suspected Endometriosis who are referred to Department of radiodiagnosis at Apollo KH Hospital, Melvisharam and satisfying the inclusion criteria. Informed consent will be taken from all the patients after explaining the study’s purpose. Detailed history including various risk factors and past illness will be taken in each case. All the patients who underwent MRI pelvis and are full filing the inclusion criteria will be taken for USG Pelvis screening. USG images of pelvis obtained using GE VOLUSON S8 PRO Ultrasound machine. Transabdominal ultrasound examination would be done by a radiologist with minimum 5 years of experience with full bladder and patient lying in supine position after good contact gel using a curvilinear probe of frequency 2-7 MHz. Subsequently Transvaginal sonography by using transvaginal probe of frequency 5-10 MHz will be done in these patients after complete evacuation of bladder to confirm the findings and search for additional lesions.
MR Non- contrast images of the pelvis is obtained using 1.5 Tesla Siemens Magnetom Essenza tim-dot system with a 8-channel body coil, and an acquisition plane in axial, oblique-coronal and sagittal planes. Imaging sequences includes sag T2, T2 Oblique coronal, T2 STIR oblique coronal, Axial T2, STIR Axial, T1 Axial, T1 FAT SAT Axial, DWI Axial. Slice thickness of 5mm. MR Non- contrast images of the abdomen is obtained using 1.5 Tesla Siemens Magnetom Essenza tim-dot system with an 8-channel body coil, and an acquisition plane in axial, oblique coronal planes. Sequence T2 TRUFI Coronal, DWI Axial. Slice thickness of 5mm. MR images will be interpreted by two different radiologist with minimum 5 years of experience.
|