BR55 in Characterization of Ovarian Lesions

Status Active, not recruiting

Clinical Trial Summary

This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.

Clinical Trial Description

A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the TS. The first 10 subjects will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55. The final cancer diagnosis will be obtained for all subjects by histopathology. ;

Study Design

Related Conditions & MeSH terms

Ovarian Cancer

Clinical Trial Details

NCT number	NCT03493464
Study type	Interventional
Source	Bracco Diagnostics, Inc
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	December 13, 2018
Completion date	December 31, 2023

View Details

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