Added Value of O-RADS in Evaluation of Ovarian Lesions

Study Overview
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Brief Summary
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To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate, the validity and reliability through pathological results and other modalities

Detailed Description
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Ultrasound (US) continues to be the initial imaging modality of choice for the identification and characterization of adnexal masses (AM) . Structured reporting of AM findings was identified by a Society of Radiologists in Ultrasound consensus working group as a target for the investigation to improve the management of women with AM . Many established guidelines and structured reporting have been developed using sonography to characterize AM, including subjective assessment, simple scoring systems, and statistically derived scoring systems . In 2008, the International Ovarian Tumor Analysis (IOTA) group proposed the use of US simple rules for the diagnosis of ovarian malignancy. These are based on a set of five US features indicative for a benign tumor (B features), and five US features indicative for a malignant tumor (M features) . In 2009, the Gynecology Imaging Reporting and Data System (GI-RADS) was designed as an attempt allowing standardized reporting of AM. This system is based on recognition patterns and criteria provided by the IOTA. The American College of Radiology (ACR) published the Ovarian-Adnexal Reporting and Data System (O-RADS), which provides an up-to-date suggestion to stratify the AM according to sonographic features. The O-RADS offers a comprehensive algorithm that categorizes AM by their possibility of being normal (O-RADS 1), to high risk of malignancy (O-RADS 5) . For the application of the US classification system of AM in clinical settings, it is essential to evaluate their validity and reproducibility. Several studies have investigated the validity of these risk stratification systems in the assessment of AM. However, data on the comparability and reproducibility of the systems are limited. The purpose of this study is To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate , the validity and reliability through pathological results.

Official Title
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Added Value of Ovarian-Adnexal Reporting and Data System in Evaluation of Ovarian Lesions

Conditions
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Ovarian Diseases

Intervention / Treatment
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* Device: Trans-abdominal Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newly diagnosed patients with ovarian lesions referred to the radiology department. Must be able to be examined. Exclusion Criteria: Patients younger than 17 years old Patient who refused to be a part of the study and undergo examination.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Trans-abdominal Ultrasound|All patients will undergo trans- abdominal and trans-vaginal examination (The trans-abdominal US was performed for virgin patients or patients with large tumors that cannot be completely seen by the TV route) performed on the devices available in South Egypt Cancer Institute in supine position. The most important b-mode parameters (such as gain, frequency, number of foci and their depth, etc.) of the US machines were manually adjusted to obtain similar image impressions. The morphological features of each AM, and independently categorized the US images of each AM according to the O-RADS published by ACR and GI-RADS simple rules . The results of consensus reviewing were used to calculate the validity of each US classification system. The definite diagnoses of AM were preferentially established based on Histo-pathological findings and other modalities.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Added value of Ovarian-Adnexal Reporting and Data System in evaluation of 30 participants with ovarian lesions regarding malignancy rate ,the validity and reliability after comparison with pathology specimens results . | Evaluation of the ovarian lesions by Trans-abdominal and Trans-vaginal Ultrasound for diagnosis of ovarian malignancy as early as possible for further management | Baseline |