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
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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 18-100 years
Treatment BR55
Clinical Study IdentifierNCT04248153
SponsorBracco Diagnostics, Inc
Last Modified on19 February 2024

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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