NCT03493464

BR55 in Characterization of Ovarian Lesions

BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 truth standard (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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	BR55	A novel targeted ultrasound contrast agent

Timeline

• Start date: 2018-12-13
• Primary completion: 2021-04-15
• Completion: 2021-07-31
• First posted: 2018-04-10
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study