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Optimal Timing of BR55 CEUS of the Ovaries
Not Recruiting
Trial ID: NCT04248153
Purpose
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.
Official Title
An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women
Eligibility
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.
Intervention(s):
drug: BR55
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brittney Williams
650-497-8588