Optimal Timing of BR55 CEUS of the Ovaries

STATUS

Recruiting
participants needed

50
sponsor

Bracco Diagnostics, Inc

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Updated on 19 February 2024

See if I qualify

cancer

hysterectomy

ovarian cancer

oophorectomy

tubal ligation

hypertension

major surgery

systemic therapy

congestive heart failure

Summary

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

Details

Condition	Ovarian disorder, Ovarian Cancer, Ovarian Cancer
Age	18years - 100years
Treatment	BR55
Clinical Study Identifier	NCT04248153
Sponsor	Bracco Diagnostics, Inc
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 HCG) 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

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Optimal Timing of BR55 CEUS of the Ovaries