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NCT Number: NCT07402421

DWI MRI for Differentiating Endometrial Lesions in Comparison With Histopathology

The aim of this study is to evaluate the diagnostic accuracy of Diffusion Weighted Magnetic Resonance Imaging (DW MRI) in differentiating benign from malignant endometrial lesions, using histopathological examination as the reference standard.

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Key information

Conditions

Endometrial Lesions

Sex eligibility

Female

Study type

Observational

Primary location

About this study

This study is designed to assess the diagnostic performance of diffusion-weighted magnetic resonance imaging (DW-MRI) in the evaluation of endometrial lesions. Women with suspected endometrial pathology who undergo pelvic MRI including diffusion-weighted sequences will be included. DW-MRI findings will be analyzed to characterize endometrial lesions based on signal intensity and apparent diffusion coefficient (ADC) values.

MRI examinations will be performed using standardized imaging protocols. Lesions will be independently assessed by experienced radiologists who are blinded to histopathological results. DW-MRI characteristics suggestive of benign or malignant pathology will be recorded and correlated with final histopathological diagnosis obtained from endometrial biopsy or surgical specimens, which will serve as the reference standard.

Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of DW-MRI in differentiating benign from malignant endometrial lesions, will be calculated. ADC values of benign and malignant lesions will be compared to determine optimal cutoff values for malignancy.

The results of this study aim to clarify the role of DW-MRI as a non-invasive imaging tool in the preoperative assessment of endometrial lesions and its potential contribution to improving diagnostic confidence and patient management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients.
  • Presenting with abnormal uterine bleeding or suspected endometrial lesions on ultrasound.

Exclusion criteria

  • Previous treatment (surgery, hormonal therapy, or radiation) for current endometrial pathology.
  • Contraindications to MRI (e.g. pacemaker and severe claustrophobia).
  • Pregnancy or renal impairment if contrast-enhanced sequences are used.

Treatment and study plan

Diagnostic imaging (DWI MRI) in comparison with histopathology

Other

Participants undergo pelvic magnetic resonance imaging including diffusion-weighted imaging sequences as part of routine diagnostic evaluation. Diffusion-weighted MRI is used to assess endometrial lesions by analyzing signal characteristics and apparent diffusion coefficient (ADC) values. No experimental treatment or additional procedures are performed beyond standard clinical care.

Primary outcomes

  1. Diffusion-Weighted Magnetic Resonance Imaging as a non-invasive tool for differentiating endometrial lesions: Accuracy in comparison with histopathology

    Time frame: From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery.

    To evaluate the diagnostic accuracy of diffusion-weighted magnetic resonance imaging (DWI-MRI) in differentiating benign from malignant endometrial lesions, using histopathological examination as the reference standard. Accuracy parameters including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy will be assessed.

  2. Diffusion-Weighted Magnetic Resonance Imaging as a non-invasive tool for differentiating endometrial lesions: Accuracy in comparison with histopathology

    Time frame: From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery, within a period of up to 4 weeks.

    To evaluate the diagnostic accuracy of diffusion-weighted magnetic resonance imaging (DWI-MRI) in differentiating benign from malignant endometrial lesions, using histopathological examination as the reference standard. Accuracy parameters including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy will be assessed.

Study contacts

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

Nardine B Nagib, Resident

CONTACT

[email protected]

01286086021

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Diffusion-Weighted Magnetic Resonance Imaging as a Non-invasive Tool for Differentiating Endometrial Lesions: Accuracy in Comparison With Histopathology

Acronym: MRI in ELs

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 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.