Endometrial LesionsMRI in ELsNCT07402421
DWI MRI for Differentiating Endometrial Lesions in Comparison With Histopathology
An observational study of Endometrial Lesions, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Lesions
- What is being tested?
- Diagnostic imaging (DWI MRI) in comparison with histopathology
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2026to 5 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include female patients presenting with abnormal uterine bleeding or suspected endometrial lesions detected on transvaginal ultrasound. Eligible participants will undergo pelvic MRI including diffusion-weighted imaging, followed by histopathological confirmation through endometrial biopsy or surgical specimens. Patients with prior treatment for the current endometrial pathology (including surgery, hormonal therapy, or radiotherapy), contraindications to MRI (such as cardiac pacemakers or severe claustrophobia), pregnancy, or renal impairment when contrast-enhanced sequences are required will be excluded.
Who may be able to join
- Female patients.
- Presenting with abnormal uterine bleeding or suspected endometrial lesions on ultrasound.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate
Nardine B Nagib, Resident, 01286086021, nardine_boshra_post@med.sohag.edu.eg
nardine_boshra_post@med.sohag.edu.eg
About this study
Official title: Diffusion-Weighted Magnetic Resonance Imaging as a Non-invasive Tool for Differentiating Endometrial Lesions: Accuracy 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.
Read the 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
- Endometrial Lesions
- Being tested
- Diagnostic imaging (DWI MRI) in comparison with histopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging (DWI MRI) in comparison with histopathologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diagnostic imaging (DWI MRI) in comparison with histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion-Weighted Magnetic Resonance Imaging as a non-invasive tool for differentiating endometrial lesions: Accuracy in comparison with histopathology
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.
Measured: From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery.
Diffusion-Weighted Magnetic Resonance Imaging as a non-invasive tool for differentiating endometrial lesions: Accuracy in comparison with histopathology
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.
Measured: From the time of MRI examination until histopathological confirmation following endometrial biopsy or surgery, within a period of up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial LesionsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardine Boshra, Sohag University
- Investigators
- Mohamed T Solyman, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402421
- Sponsor's protocol ID
- Soh-Med-26-1-4MS
- Acronym
- MRI in ELs
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-Weighted Magnetic Resonance Imaging as a Non-invasive Tool for Differentiating Endometrial Lesions: Accuracy in Comparison With Histopathology
- ClinicalTrials.gov ID
- NCT07402421
- Acronym / sponsor ID
- MRI in ELs / Soh-Med-26-1-4MS
- Conditions
- Endometrial Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected endometrial lesions | – | Other: Diagnostic imaging (DWI MRI) in comparison with histopathologyThis 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include female patients presenting with abnormal uterine bleeding or suspected endometrial lesions detected on transvaginal ultrasound. Eligible participants will undergo pelvic MRI including diffusion-weighted imaging, followed by histopathological confirmation through endometrial biopsy or surgical specimens. Patients with prior treatment for the current endometrial pathology (including surgery, hormonal therapy, or radiotherapy), contraindications to MRI (such as cardiac pacemakers or severe claustrophobia), pregnancy, or renal impairment when contrast-enhanced sequences are required will be excluded.
Key inclusion criteria (2 listed)
- Female patients.
- Presenting with abnormal uterine bleeding or suspected endometrial lesions on ultrasound.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic 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. | Other | Patients with suspected endometrial lesions |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed T Solyman, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Lesions, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nardine B Nagib, Resident (01286086021, nardine_boshra_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.