BR55 in Characterization of Ovarian Lesions

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.

Inclusion Criteria: Enroll a subject if he/she meets the following inclusion criteria:

- Is at least 18 years of age;

- Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;

- Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier
than 24 hours and not later than 30 days following BR55 administration;

- Provides written Informed Consent and is willing to comply with protocol requirements.

Exclusion Criteria: Exclude a subject if the subject does not fulfill the inclusion
criteria, or if any of the following conditions are observed:

- Is a pregnant or lactating female. Exclude the possibility of pregnancy:

- by testing on site at the institution (serum βHCG) within 24 hours prior to the
start of investigational product administration,

- by surgical history (e.g., tubal ligation or hysterectomy),

- by post-menopausal status with a minimum 1 year without menses;

- Has undergone prior systemic therapy for ovarian cancer;

- Has history of concurrent malignancy;

- Has history of any clinically unstable cardiac condition including class III/IV
congestive heart failure;

- Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;

- Has severe pulmonary hypertension (pulmonary artery pressure >90mmHg) or uncontrolled
systemic hypertension and/or respiratory distress syndrome;

- Has open and/or non-healing wounds in the chest, abdomen and pelvis;

- Has other systemic vascular abnormalities associated with neovascularization, such as
macular degeneration, that in the opinion of the investigator could significantly
affect the ability to evaluate the effects of BR55;

- Is participating in a clinical trial or has participated in another trial with an
investigational compound within the past 30 days prior to enrolment;

- Has previously been enrolled in and completed this study;

- Has any known allergy to one or more of the ingredients of the Investigational Product
or to any other contrast media;

- Is determined by the Investigator that the subject is clinically unsuitable for the
study;

- Has had major surgery, including laparoscopic surgery, within 3 months prior to
enrolment;

- Has history of surgery to the ovaries or pelvic inflammatory disease.