Optimal Timing of BR55 CEUS of the Ovaries | NCT04248153

NCT04248153

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
National Institutes of Health (NIH)	NIH

Label	Type	Description	Intervention Names
Group A	Experimental	BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.	Drug: BR55
Group B	Experimental	BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.	Drug: BR55

Name	Type	Description	Arm Group Labels	Other Names
BR55	Drug	BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg	Group A Group B

Measure	Description	Time Frame
Adverse Events	Number of participants who received the contrast agent and experienced an adverse event.	From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

Eligibility Module

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.

Name	Affiliation	Role
Luigia Storto, MD	Bracco Diagnostics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Palo Alto	California	94304	United States

Arm/Group Information

ID	Title	Description
FG000	Training Cases	Up to 3 subjects were to be enroll as "training cases" to determine the optimal imaging technique with BR55 and a 2D intracavitary probe for this study population. These subjects were to receive a single CEUS examination with administration of BR55 at a dose of 0.03 mL/kg, undergo all safety evaluations but not the efficacy assessments and were not required to undergo oophorectomy. Timing of the CEUS examination with respect to follicular phase of the menstrual cycle was not to be considered.
FG001	Group A	BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter. BR55: BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg No study participant was enrolled in this group.
FG002	Group B	BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter. BR55: BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg No study participant was enrolled in this group.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Training Cases	Up to 3 subjects were to be enroll as "training cases" to determine the optimal imaging technique with BR55 and a 2D intracavitary probe for this study population. These subjects were to receive a single CEUS examination with administration of BR55 at a dose of 0.03 mL/kg, undergo all safety evaluations but not the efficacy assessments and were not required to undergo oophorectomy. Timing of the CEUS examination with respect to follicular phase of the menstrual cycle was not to be considered.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adverse Events

Number of participants who received the contrast agent and experienced an adverse event.

The only participants enrolled in this study were 3 "training cases." No other study participant was enrolled in the study; therefore, there are no results for Group A and Group B.

Posted

Count of Participants

Participants

From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

ID	Title	Description
OG000	Training Cases	Up to 3 subjects were to be enroll as "training cases" to determine the optimal imaging technique with BR55 and a 2D intracavitary probe for this study population. These subjects were to receive a single CEUS examination with administration of BR55 at a dose of 0.03 mL/kg, undergo all safety evaluations but not the efficacy assessments and were not required to undergo oophorectomy. Timing of the CEUS examination with respect to follicular phase of the menstrual cycle was not to be considered.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Training Cases	Up to 3 subjects were to be enroll as "training cases" to determine the optimal imaging technique with BR55 and a 2D intracavitary probe for this study population. These subjects were to receive a single CEUS examination with administration of BR55 at a dose of 0.03 mL/kg, undergo all safety evaluations but not the efficacy assessments and were not required to undergo oophorectomy. Timing of the CEUS examination with respect to follicular phase of the menstrual cycle was not to be considered.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases