Adnexal LesionNCT07334184
Role of Magnetic Resonance Imaging in Diagnosis of Adnexal Cystic Lesions
An observational study of Adnexal Lesion, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in characterizing adnexal cystic lesions and differentiating benign from malignant lesions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Adnexal Lesion
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Dec 2025to 10 Jan 2027
- 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: The study population will consist of 50 female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants are those with indeterminate or suspicious ultrasound findings requiring further characterization with MRI. Patients will provide written and oral informed consent prior to inclusion.
Who may be able to join
- Female patients of any age with adnexal cystic lesions detected by ultrasound
- Adnexal lesions that are indeterminate or suspicious on ultrasound
- Patients who provide written and oral informed consent
Who cannot join
- Patients unwilling to participate or complete the study
- Contraindications to MRI, including claustrophobia, metallic implants, pacemaker, or prosthetic heart valves
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Magnetic Resonance Imaging in the Diagnostic Evaluation of Adnexal Cystic Lesions.
This prospective study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in characterizing adnexal cystic lesions and differentiating benign from malignant lesions. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed, to improve diagnostic confidence and guide appropriate patient management.
Read the detailed description
Adnexal cystic lesions are commonly encountered in gynecologic imaging and may represent a spectrum of benign and malignant conditions. While ultrasound is the first-line imaging modality due to its accessibility and safety, many adnexal masses remain indeterminate.
Magnetic resonance imaging (MRI) provides superior soft-tissue contrast and multiparametric imaging, including T1-, T2-weighted sequences, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE), allowing better characterization of adnexal lesions. Features such as solid tissue, papillary projections, thick septa, and restricted diffusion help differentiate malignant from benign lesions.
This prospective study at Sohag University Hospital will include 50 female patients with adnexal cystic lesions detected on ultrasound. MRI findings will be correlated with histopathology, surgical data, laboratory results (CA-125), or follow-up imaging when surgery is not performed. The study aims to assess the diagnostic accuracy of MRI in differentiating benign from malignant adnexal lesions and to improve clinical decision-making regarding patient management.
- Conditions
- Adnexal Lesion
- Being tested
- Magnetic Resonance Imaging
- Keywords
- adnexal lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Magnetic resonance imaging (MRI) of the pelvis will be performed using 1.5T or 3T scanners with a phased-array pelvic coil. The protocol will include axial, sagittal, and coronal T2-weighted images, axial T1-weighted and fat-suppressed T1-weighted images, diffusion-weighted imaging with ADC maps, and dynamic contrast-enhanced sequences when clinically indicated and not contraindicated.
| Study group | Role | What they receive |
|---|---|---|
| adnexal cystic lesions cohort | This group consists of female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants have indeterminate or suspicious ultrasound findings and will undergo MRI for further characterization. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of MRI in characterization of adnexal cystic lesions
Assessment of the diagnostic performance of magnetic resonance imaging (MRI) in differentiating benign from malignant adnexal cystic lesions, using histopathology, intraoperative findings, or follow-up imaging as the reference standard. Diagnostic accuracy will be expressed in terms of sensitivity, specificity, and predictive values.
Measured: From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start26 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal LesionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mira Noshey Mehawed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334184
- Sponsor's protocol ID
- Adnexal-Lesions-Radiology-2025
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. All patient data will remain confidential and used solely for the purposes of this study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Magnetic Resonance Imaging in the Diagnostic Evaluation of Adnexal Cystic Lesions.
- ClinicalTrials.gov ID
- NCT07334184
- Acronym / sponsor ID
- Adnexal-Lesions-Radiology-2025
- Conditions
- Adnexal Lesion
- Keywords
- adnexal lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 12 Jan 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.
This prospective study aims to evaluate the diagnostic accuracy of magnetic resonance imaging (MRI) in characterizing adnexal cystic lesions and differentiating benign from malignant lesions. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed, to improve diagnostic confidence and guide appropriate patient management.
Detailed description
Adnexal cystic lesions are commonly encountered in gynecologic imaging and may represent a spectrum of benign and malignant conditions. While ultrasound is the first-line imaging modality due to its accessibility and safety, many adnexal masses remain indeterminate.
Magnetic resonance imaging (MRI) provides superior soft-tissue contrast and multiparametric imaging, including T1-, T2-weighted sequences, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE), allowing better characterization of adnexal lesions. Features such as solid tissue, papillary projections, thick septa, and restricted diffusion help differentiate malignant from benign lesions.
This prospective study at Sohag University Hospital will include 50 female patients with adnexal cystic lesions detected on ultrasound. MRI findings will be correlated with histopathology, surgical data, laboratory results (CA-125), or follow-up imaging when surgery is not performed. The study aims to assess the diagnostic accuracy of MRI in differentiating benign from malignant adnexal lesions and to improve clinical decision-making regarding patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adnexal cystic lesions cohort | – | Diagnostic Test: Magnetic Resonance ImagingThis group consists of female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants have indeterminate or suspicious ultrasound findings and will undergo MRI for further characterization. MRI findings will be correlated with histopathology, surgical data, laboratory results, or follow-up imaging when surgery is not performed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of 50 female patients of all ages presenting to the Radiology Department at Sohag University Hospital with adnexal cystic lesions detected on ultrasound. Eligible participants are those with indeterminate or suspicious ultrasound findings requiring further characterization with MRI. Patients will provide written and oral informed consent prior to inclusion.
Key inclusion criteria (3 listed)
- Female patients of any age with adnexal cystic lesions detected by ultrasound
- Adnexal lesions that are indeterminate or suspicious on ultrasound
- Patients who provide written and oral informed consent
Key exclusion criteria (2 listed)
- Patients unwilling to participate or complete the study
- Contraindications to MRI, including claustrophobia, metallic implants, pacemaker, or prosthetic heart valves
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic resonance imaging (MRI) of the pelvis will be performed using 1.5T or 3T scanners with a phased-array pelvic coil. The protocol will include axial, sagittal, and coronal T2-weighted images, axial T1-weighted and fat-suppressed T1-weighted images, diffusion-weighted imaging with ADC maps, and dynamic contrast-enhanced sequences when clinically indicated and not contraindicated. | Diagnostic test | adnexal cystic lesions cohort |
Primary outcome
Diagnostic accuracy of MRI in characterization of adnexal cystic lesions
Time frame: From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months
Assessment of the diagnostic performance of magnetic resonance imaging (MRI) in differentiating benign from malignant adnexal cystic lesions, using histopathology, intraoperative findings, or follow-up imaging as the reference standard. Diagnostic accuracy will be expressed in terms of sensitivity, specificity, and predictive values.
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 12 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. All patient data will remain confidential and used solely for the purposes of this study.
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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.
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 Adnexal Lesion, 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 3 inclusion and 2 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 12 Jan 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 Mira Noshey Mehawed Abed El Nor, MBBCH (+01288264655, mera_noshy_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?
Diagnostic accuracy of MRI in characterization of adnexal cystic lesions (time frame: From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months). 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 12 Jan 2026.