Trial Outcomes & Findings for BR55 in Characterization of Ovarian Lesions (NCT NCT03493464)

Last Updated: 2024-09-19

Results Overview

BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

30 minutes post-dose on Day 1

Results posted on

2024-09-19

Participant Flow

A total of 60 subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 contrast-enhanced ultrasound (CEUS) examination were to be enrolled to obtain approx. 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the Truth Standard (TS; histopathology). This study was terminated early due to expiration of available BR55, therefore, only 14 of the 60 anticipated participants in the study were enrolled.

A subject was to be enrolled in the study if the following inclusion criteria were met: was at least 18 years old; had an ovarian lesion that was visible and assessable with trans-vaginal ultrasound; was scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following BR55 administration; and provided written Informed Consent and was willing to comply with protocol requirements.

Participant milestones

Participant milestones
Measure	Treatment All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Overall Study Surgery not performed	1

Baseline Characteristics

BR55 in Characterization of Ovarian Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=14 Participants All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	55.4 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Exposure to Investigational Product	2.16 Actual Volume Administered (mL) STANDARD_DEVIATION 0.246 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes post-dose on Day 1

Population: All participants enrolled and dosed in the study with BR55 enhancement assessed at 30 minutes post-dose timepoint.

Outcome measures

Outcome measures
Measure	Treatment n=14 Participants All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Visual Assessment of BR55 Enhancement No enhancement	5 Participants
Visual Assessment of BR55 Enhancement Weak enhancement	6 Participants
Visual Assessment of BR55 Enhancement Strong enhancement	3 Participants

PRIMARY outcome

Timeframe: 2 days (day of and 24 hours after BR55 administration)

Population: All participants enrolled and dosed in the study

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

Outcome measures

Outcome measures
Measure	Treatment n=14 Participants All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Adverse Events	3 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=14 participants at risk All subjects received a single dose of BR55 at 0.03 mL/kg in this study. No subject received a single dose of BR55 at 0.05 mL/kg. BR55: A novel targeted ultrasound contrast agent
Nervous system disorders Headache	21.4% 3/14 • Number of events 3 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to 3 days. Any untoward medical non-pre-existing symptom or medically significant laboratory or instrumental (e.g., electrocardiographic) abnormality, as well as worsening of pre-existing ones were considered to be an adverse event. All untoward medical occurrences, as well as the intensity (mild, moderate, severe), relationship (reasonable or no reasonable possibility)
General disorders Itchiness	7.1% 1/14 • Number of events 1 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to 3 days. Any untoward medical non-pre-existing symptom or medically significant laboratory or instrumental (e.g., electrocardiographic) abnormality, as well as worsening of pre-existing ones were considered to be an adverse event. All untoward medical occurrences, as well as the intensity (mild, moderate, severe), relationship (reasonable or no reasonable possibility)

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