Trial Outcomes & Findings for A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer (NCT NCT02142608)

Last Updated: 2021-03-29

Results Overview

To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Within 30 minutes after administration of BR55

Results posted on

2021-03-29

Participant Flow

19 patients were recruited, but only 18 were dosed. Of the 18 dosed, 4 were training cases evaluated for safety only. Of the remaining 14 patients, 1 had no evaluable images; therefore, only 13 patients were included in the Efficacy Population.

One participant was not dosed with BR55. Patient signed informed consent but did not receive investigational product. During pre-dose safety evaluations, it was discovered that patient may have potentially clinical significant abnormal ECGs (atrial fibrillation).

Participant milestones

Participant milestones
Measure	BR55 All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BR55 n=18 Participants All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Age, Customized >= 65 years	6 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Weight	83.62 kg STANDARD_DEVIATION 15.573 • n=5 Participants
Height	172.6 cm STANDARD_DEVIATION 8.71 • n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 4.68 • n=5 Participants
Age, Customized 18-64 years	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes after administration of BR55

Population: BR55 binding level versus Gleason score in malignant lesions from off-site histopathology

To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard

Outcome measures

Outcome measures
Measure	BR55 n=13 Participants Ultrasound Image Assessment
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging Gleason score ≥7	17 number of lesions
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging With binding	8 number of lesions

SECONDARY outcome

Timeframe: 24 hours post-dose

To obtain safety data in subjects administered BR55

Outcome measures

Outcome measures
Measure	BR55 n=18 Participants Ultrasound Image Assessment
Number of Participants With Adverse Events Number of subjects with AEs	1 participants
Number of Participants With Adverse Events Number of subjects with AEs by intensity - Mild	1 participants
Number of Participants With Adverse Events Number of subjects with AEs by intensity -Moderate	0 participants
Number of Participants With Adverse Events Number of subjects with AEs by intensity - Severe	0 participants
Number of Participants With Adverse Events Number of subjects with serious AEs	0 participants
Number of Participants With Adverse Events Number of subjects who discontinued due to AEs	0 participants
Number of Participants With Adverse Events Number of deaths	0 participants

Adverse Events

BR55

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BR55 n=18 participants at risk All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • All adverse events that occurred from the time the patient signed the Informed Consent Form until 24 hours after the last administration of BR55 were recorded.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • All adverse events that occurred from the time the patient signed the Informed Consent Form until 24 hours after the last administration of BR55 were recorded.

Additional Information

Maria Luigia Storto, MD, Executive Director X-Ray and Ultrasound

Bracco Diagnostics Inc.

Phone: 609-514-2262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place