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临床试验/NCT03175991
NCT03175991已完成不适用

Gynacological Imaging Reporting and Data System in Classifying Ovarian Masses on the Basis of Ultrasonography

Assiut University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2018年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
The resistivity index

研究概览

简要总结

Ovarian masses are common problems in clinical practice. Sonography is considered the firstline imaging technique for discriminating between malignant and benign lesions, and it has been shown to be useful for determining optimal treatment.

详细描述

Transvaginal Ultrasonography has been demonstrated to be the most sensitive and effective technique, being also non-invasive and in-expensive maneuver.Since in early reports, a standardized method for the description of the sonographic appearance of the ovarian masses was not used, the data of different studies are not easily compared.

In addition, there is no consensus on sonographic diagnostic criteria for ovarian cancer, despite many ultrasonography features being considered to be predictive of malignancy, such as presence of septations, internal nodularity, wall thickening, solid areas, free fluid or bilaterality.Usually the clinical management decision is based on data provided in the sonographic report. Many sonographers and sonologists use scoring systems to characterize ovarian masses, whereas others use the so called pattern recognition approach However, sometimes sonographic reports are misleading and confusing for the clinician. Although some groups have made considerable efforts in establishing terms and definitions for sonographic findings in ovarian masses .

In this study, we proposed a new data reporting system for sonographic findings in ovarian masses. This system is based on the concept developed for breast imaging, namely the Breast Imaging Reporting and Data System classification. Originally developed for mammographic findings, it has been successfully applied to breast sonography.

Like its breast sonographic counterpart, the gynacological imaging reporting and data system in ovarian masses by ultrasonography lexicon is intended to provide a unified language for sonographic reporting and for avoiding confusion in communication between the sonographer / sonologist and the clinician..

This system is based on a description of the ovarian mass using the pattern recognition approach and color Doppler blood flow location and the prior risk for malignancy in each group. On this basis, the proposed classification enables the sonologist or sonographer to give the clinician as much information as possible in a summarized way, as well as an estimated risk of malignancy, based only on the sonographic characteristics of the images.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • All women of different age groups diagnosed as having an ovarian mass.
  • Accidentally discovered ovarian mass in non-complaining female.
  • Patients known to have primary that may give metastasis to the ovaries.

排除标准

  • Patients receive neo adjuvant chemotherapy
  • Recurrent ovarian masses

结局指标

主要结局

The resistivity index

时间窗: 10 minutes

The resistive index will be automatically calculated from at least 3 consecutive flow velocity waveforms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hagar Desoky

Principle investigator

Assiut University

研究点 (1)

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