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NCT Number: NCT07334184

Role of Magnetic Resonance Imaging in Diagnosis 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.

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Key information

Conditions

Adnexal Lesion

Sex eligibility

Female

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mira Noshey Mehawed Abed El Nor, MBBCH

CONTACT

[email protected]

+01288264655

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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