DWI MRI for Differentiating Endometrial Lesions in Comparison With Histopathology (MRI in ELs)
Diffusion-Weighted Magnetic Resonance Imaging as a Non-invasive Tool for Differentiating Endometrial Lesions: Accuracy in Comparison With Histopathology
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nardine B Nagib, Resident
- Phone Number: 01286086021
- Email: nardine_boshra_post@med.sohag.edu.eg
Study Locations
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Sohag Governorate
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Sohag, Sohag Governorate, Egypt
- Sohag university hospital
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Contact:
- Nardine B Nagib, Resident
- Phone Number: 01286086021
- Email: nardine_boshra_post@med.sohag.edu.eg
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Contact:
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Principal Investigator:
- Nardine B Nagib, Resident
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with suspected endometrial lesions
This cohort includes women with clinically or radiologically suspected endometrial lesions who undergo pelvic magnetic resonance imaging with diffusion-weighted sequences.
Diffusion-weighted MRI findings, including signal characteristics and apparent diffusion coefficient (ADC) values, are evaluated and compared with histopathological examination results obtained from endometrial biopsy or surgical specimens, which serve as the reference standard.
No therapeutic intervention is assigned as part of this study.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery.
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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.
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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.
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From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery, within a period of up to 4 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed T Solyman, MD
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-1-4MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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