- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334184
Role of Magnetic Resonance Imaging in Diagnosis of Adnexal Cystic Lesions
Role of Magnetic Resonance Imaging in the Diagnostic Evaluation of Adnexal Cystic Lesions.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mira Noshey Mehawed Abed El Nor, MBBCH
- Phone Number: +01288264655
- Email: mera_noshy_post@med.sohag.edu.eg
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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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 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
Exclusion Criteria:
- Patients unwilling to participate or complete the study
- Contraindications to MRI, including claustrophobia, metallic implants, pacemaker, or prosthetic heart valves
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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From MRI examination until final diagnosis (surgery, histopathology, or follow-up imaging), up to 6 months
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Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adnexal-Lesions-Radiology-2025
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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