Ovarian Cancer
Conditions
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.
Interventions
DRUGBR55
BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg
Sponsors
National Institutes of Health (NIH)
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days | Number of participants who received the contrast agent and experienced an adverse event. |
Countries
United States
Participant flow
Pre-assignment details
Up to 50 subjects were to be enrolled in the study: the first 3 as training cases, the remaining divided between Group A and Group B.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 0 |
| 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. | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Total | Training Cases |
|---|---|---|
| Actual Volume (mL) Injected | 2.06 mL | 2.06 mL |
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Age, Continuous | 38.3 years | 38.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 3 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Adverse Events
Number of participants who received the contrast agent and experienced an adverse event.
Time frame: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Training Cases | Adverse Events | 0 Participants |