NCT07334184

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 26, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 31, 2025

Last Update Submit

December 31, 2025

Conditions

Keywords

adnexal lesions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months

Study Arms (1)

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.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

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.

adnexal cystic lesions cohort

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biologically female patients with adnexal cystic lesions are eligible, regardless of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients unwilling to participate or complete the study
  • Contraindications to MRI, including claustrophobia, metallic implants, pacemaker, or prosthetic heart valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mira Noshey Mehawed Abed El Nor, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 12, 2026

Study Start

December 26, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 10, 2027

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. All patient data will remain confidential and used solely for the purposes of this study.

Locations