Trial Outcomes & Findings for Optimal Timing of BR55 CEUS of the Ovaries (NCT NCT04248153)
NCT ID: NCT04248153
Last Updated: 2024-08-23
Results Overview
Number of participants who received the contrast agent and experienced an adverse event.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days
Results posted on
2024-08-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Timing of BR55 CEUS of the Ovaries
Baseline characteristics by cohort
| Measure |
Training Cases
n=3 Participants
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.
|
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.
|
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
—
|
—
|
3 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
38.3 years
n=99 Participants
|
—
|
—
|
38.3 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
—
|
—
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
—
|
—
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
—
|
—
|
3 participants
n=7 Participants
|
|
Actual Volume (mL) Injected
|
2.06 mL
n=99 Participants
|
—
|
—
|
2.06 mL
n=7 Participants
|
PRIMARY outcome
Timeframe: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 daysPopulation: 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.
Number of participants who received the contrast agent and experienced an adverse event.
Outcome measures
| Measure |
Training Cases
n=3 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Adverse Events
|
0 Participants
|
—
|
—
|
Adverse Events
Training Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Giordana Marioni, Clinical Trial Assistant
Bracco Diagnostics Inc.
Phone: 609-514-2282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place