Role of Magnetic Resonance Imaging in Diagnosis of Adnexal Cystic Lesions

December 31, 2025 updated by: Mira Noshey Mehawed, Sohag University

Role of Magnetic Resonance Imaging in the Diagnostic Evaluation of Adnexal Cystic Lesions.

This prospective study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in characterizing adnexal cystic lesions and differentiating benign from malignant lesions. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed, to improve diagnostic confidence and guide appropriate patient management.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Adnexal cystic lesions are commonly encountered in gynecologic imaging and may represent a spectrum of benign and malignant conditions. While ultrasound is the first-line imaging modality due to its accessibility and safety, many adnexal masses remain indeterminate.

Magnetic resonance imaging (MRI) provides superior soft-tissue contrast and multiparametric imaging, including T1-, T2-weighted sequences, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE), allowing better characterization of adnexal lesions. Features such as solid tissue, papillary projections, thick septa, and restricted diffusion help differentiate malignant from benign lesions.

This prospective study at Sohag University Hospital will include 50 female patients with adnexal cystic lesions detected on ultrasound. MRI findings will be correlated with histopathology, surgical data, laboratory results (CA-125), or follow-up imaging when surgery is not performed. The study aims to assess the diagnostic accuracy of MRI in differentiating benign from malignant adnexal lesions and to improve clinical decision-making regarding patient management.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 50 female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants are those with indeterminate or suspicious ultrasound findings requiring further characterization with MRI. Patients will provide written and oral informed consent prior to inclusion.

Description

Inclusion Criteria:

  • Female patients of any age with adnexal cystic lesions detected by ultrasound
  • Adnexal lesions that are indeterminate or suspicious on ultrasound
  • Patients who provide written and oral informed consent

Exclusion Criteria:

  • Patients unwilling to participate or complete the study
  • Contraindications to MRI, including claustrophobia, metallic implants, pacemaker, or prosthetic heart valves

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adnexal cystic lesions cohort
This group consists of female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants have indeterminate or suspicious ultrasound findings and will undergo MRI for further characterization. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed.
Magnetic resonance imaging (MRI) of the pelvis will be performed using 1.5T or 3T scanners with a phased-array pelvic coil. The protocol will include axial, sagittal, and coronal T2-weighted images, axial T1-weighted and fat-suppressed T1-weighted images, diffusion-weighted imaging with ADC maps, and dynamic contrast-enhanced sequences when clinically indicated and not contraindicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of MRI in characterization of adnexal cystic lesions
Time Frame: From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months
Assessment of the diagnostic performance of magnetic resonance imaging (MRI) in differentiating benign from malignant adnexal cystic lesions, using histopathology, intraoperative findings, or follow-up imaging as the reference standard. Diagnostic accuracy will be expressed in terms of sensitivity, specificity, and predictive values.
From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 26, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Adnexal-Lesions-Radiology-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. All patient data will remain confidential and used solely for the purposes of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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