Clinical trial NCT04248153: Optimal Timing of BR55 CEUS of the Ovaries
Official title: An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-01-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: BR55 CEUS will be performed in the early follicular phase first and in the late follicular phase thereafter; Group B: BR55 CEUS will be performed in the late follicular phase first and in the early phase thereafter.
Primary purpose: DIAGNOSTIC

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Bracco Diagnostics
name: Luigia Storto, MD
role: STUDY_DIRECTOR
References: