Gynacological Imaging Reporting and Data System in Ovarian Masses by Ultrasonography

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175991
• Other study ID #: HAGAR098765
• Status: Completed
• Start date: July 5, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Currently, there is enough evidence to indicate that when an experienced examiner performs the sonographic examination, such accuracy is achievable for most types of ovarian masses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 1, 2019
• Est. primary completion date: February 26, 2019
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients receive neo adjuvant chemotherapy

• Recurrent ovarian masses

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Diagnostic Test:
• ultrasonography
A morphologic evaluation will be performed according to International Ovarian Tumor Analysis Group recommendations for the following parameters: Bilaterality , wall thickness, septations , papillary projections, solid areas, and echogenicity. The presence of ascites also will be recorded. Pattern recognition analysis will be used for ovarian masses highly suggestive of some diseases , then color Doppler will be activated to identify vascular color signals within the lesion.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine-Assuit Univeristy	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Zhang T, Li F, Liu J, Zhang S. Diagnostic performance of the Gynecology Imaging Reporting and Data System for malignant adnexal masses. Int J Gynaecol Obstet. 2017 Jun;137(3):325-331. doi: 10.1002/ijgo.12153. Epub 2017 Apr 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The resistivity index	The resistive index will be automatically calculated from at least 3 consecutive flow velocity waveforms	10 minutes