BR55 in Characterization of Ovarian Lesions
Trial ID or NCT#
NCT03493464
Status
NOT RECRUITING
Purpose
This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.
Official Title
BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Mahima Goel
650.723.0371
View on ClinicalTrials.gov
