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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
A novel targeted ultrasound contrast agent
Stanford University Medical Center
Palo Alto, California, United States
Visual Assessment of BR55 Enhancement
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).
Time frame: 30 minutes post-dose on Day 1
Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Time frame: 2 days (day of and 24 hours after BR55 administration)
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