Trial Outcomes & Findings for Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions (NCT NCT03486327)
NCT ID: NCT03486327
Last Updated: 2024-08-23
Results Overview
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to 24 hours post-dose on Day 1
Results posted on
2024-08-23
Participant Flow
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
Participant milestones
| Measure |
0.03mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent
|
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Baseline characteristics by cohort
| Measure |
0.03mL/kg Dose Group
n=4 Participants
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent
|
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
—
|
—
|
65.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
—
|
—
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
—
|
—
|
4 participants
n=4 Participants
|
|
Total Volume (mL) Injected
|
2.00 mL
n=5 Participants
|
—
|
—
|
2.00 mL
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dose on Day 1Population: As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
Outcome measures
| Measure |
0.03mL/kg Dose Group
n=4 Participants
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent
|
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
|---|---|---|---|
|
1. Visual Assessment of Enhancement
No enhancement
|
0 Participants
|
—
|
—
|
|
1. Visual Assessment of Enhancement
Weak enhancement
|
3 Participants
|
—
|
—
|
|
1. Visual Assessment of Enhancement
Strong enhancement
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 daysPopulation: As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
Number of participants who received the contrast agent and experienced an adverse event.
Outcome measures
| Measure |
0.03mL/kg Dose Group
n=4 Participants
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent
|
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
|---|---|---|---|
|
2. Adverse Events
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
0.03mL/kg Dose Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.05mL/kg Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.08mL/kg Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.03mL/kg Dose Group
n=4 participants at risk
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.
BR55: A novel targeted ultrasound contrast agent
|
0.05mL/kg Dose Group
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
0.08mL/kg Dose Group
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
BR55: A novel targeted ultrasound contrast agent
No study participant was enrolled in this group.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
—
0/0 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
—
0/0 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
—
0/0 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
—
0/0 • Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.
As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.
|
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