Optimal Timing of BR55 CEUS of the Ovaries

An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women

This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.

Inclusion Criteria: Enroll a subject in this study if the subject meets the following inclusion criteria:

• Is a female subject of at least 18 years of age;
• Is premenopausal;
• Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second BR55 CEUS examination;
• Provides written Informed Consent and is willing to comply with protocol requirements.

Exclusion Criteria: Exclude a subject from this study 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),

• 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 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.