Optimal Timing of BR55 CEUS of the Ovaries
- Conditions
- Ovarian Cancer
- Registration Number
- NCT04248153
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- Female
- Target Recruitment
- 3
Inclusion Criteria: Enroll a subject in this study if the subject meets the following<br>inclusion criteria:<br><br> - Is a female subject of at least 18 years of age;<br><br> - Is premenopausal;<br><br> - Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian<br> cancer not earlier than 24 hours and not later than 5 days following the second BR55<br> CEUS examination;<br><br> - Provides written Informed Consent and is willing to comply with protocol<br> requirements.<br><br>Exclusion Criteria: Exclude a subject from this study if the subject does not fulfill the<br>inclusion criteria, or if any of the following conditions are observed:<br><br> - Is a pregnant or lactating female. Exclude the possibility of pregnancy:<br><br> - by testing on site at the institution (serum ßHCG) within 24 hours prior to the<br> start of investigational product administration,<br><br> - by surgical history (e.g., tubal ligation or hysterectomy),<br><br> - Has undergone prior systemic therapy for ovarian cancer;<br><br> - Has history of concurrent malignancy;<br><br> - Has history of any clinically unstable cardiac condition including class III/IV<br> congestive heart failure;<br><br> - Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;<br><br> - Has severe pulmonary hypertension (pulmonary artery pressure >90mmHg) or<br> uncontrolled systemic hypertension and/or respiratory distress syndrome;<br><br> - Has open and/or non-healing wounds in the chest, abdomen and pelvis;<br><br> - Has other systemic vascular abnormalities associated with neovascularization that in<br> the opinion of the investigator could significantly affect the ability to evaluate<br> the effects of BR55;<br><br> - Is participating in a clinical trial or has participated in another trial with an<br> investigational compound within the past 30 days prior to enrolment;<br><br> - Has previously been enrolled in and completed this study;<br><br> - Has any known allergy to one or more of the ingredients of the Investigational<br> Product or to any other contrast media;<br><br> - Is determined by the Investigator that the subject is clinically unsuitable for the<br> study;<br><br> - Has had major surgery, including laparoscopic surgery, within 3 months prior to<br> enrolment;<br><br> - Has history of surgery to the ovaries or pelvic inflammatory disease.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events
- Secondary Outcome Measures
Name Time Method