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Clinical Trials/CTRI/2025/09/095135
CTRI/2025/09/095135
Not yet recruiting
Not Applicable

Efficiency of ultrasonography compared to magnetic resonance imaging in the diagnosis of endometriosis.

APOLLO KH HOSPITAL1 site in 1 country30 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
APOLLO KH HOSPITAL
Enrollment
30
Locations
1
Primary Endpoint
Compare the diagnostic accuracy of ultrasonography with magnetic resonance imaging in patients of endometriosis.

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Compare the diagnostic accuracy of ultrasonography with magnetic resonance imaging in patients of endometriosis.

Time Frame: BASELINE MRI | AFTER 1 HOUR TRANSVAGINAL ULTRASOUND AND THEN AFTER 1 HOUR DIAGNOSIS AND REPORTING.

Secondary Outcomes

  • Correlation of patient’s symptoms with imaging findings in Ultrasonography & MRI.(The various types of complications in patients with endometriosis.)

Investigators

Sponsor
APOLLO KH HOSPITAL
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Monika Jain

APOLLO KH HOSPITAL

Study Sites (1)

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