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Not Yet RecruitingNCT07402421

DWI MRI for Differentiating Endometrial Lesions in Comparison With Histopathology

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERDiagnostic imaging (DWI MRI) in comparison with histopathologyParticipants 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.

Timeline

Start date
2026-02-05
Primary completion
2026-05-05
Completion
2026-06-05
First posted
2026-02-11
Last updated
2026-02-11

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07402421. Inclusion in this directory is not an endorsement.