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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07402421
Acronym
MRI in ELs
Enrollment
30
Registered
2026-02-11
Start date
2026-02-05
Completion date
2026-06-05
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Lesions

Brief 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.

Interventions

OTHERDiagnostic imaging (DWI MRI) in comparison with histopathology

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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

CONTACTNardine B Nagib, Resident
nardine_boshra_post@med.sohag.edu.eg01286086021
PRINCIPAL_INVESTIGATORMohamed T Solyman, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026