BR55 in Characterization of Ovarian Lesions

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.