A Phase 1/2 interventional study of BR55 in Prostate Cancer, sponsored by Bracco Diagnostics, Inc. Completed at 2 sites in 2 countries. Open to male participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Bracco Diagnostics, Inc · Phase 1/2, Interventional, and Diagnostic
Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results
This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 19 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bracco Diagnostics, Inc is the lead sponsor of 48 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
Drug: BR55
Ultrasound contrast agent
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Time frame: Within 30 minutes after administration of BR55
Number of Participants With Adverse Events
To obtain safety data in subjects administered BR55
Time frame: 24 hours post-dose
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.
| Milestone | BR55 |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
| number of lesions | BR55 |
|---|---|
| Gleason score ≥7 | 17 |
| With binding | 8 |
To obtain safety data in subjects administered BR55
| participants | BR55 |
|---|---|
| Number of subjects with AEs | 1 |
| Number of subjects with AEs by intensity - Mild | 1 |
| Number of subjects with AEs by intensity -Moderate | 0 |
| Number of subjects with AEs by intensity - Severe | 0 |
| Number of subjects with serious AEs | 0 |
| Number of subjects who discontinued due to AEs | 0 |
| Number of deaths | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BR55 | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | BR55 |
|---|---|
| DiarrheaGastrointestinal disorders | 1/18 |
| HeadacheNervous system disorders | 1/18 |
| Age, Continuous(years) | BR55 |
|---|---|
| Mean | 62.6 ± 4.68 |
| Age, Customized(Participants) | BR55 |
|---|---|
| 18-64 years | 12 |
| >= 65 years | 6 |
| Sex: Female, Male(Participants) | BR55 |
|---|---|
| Female | 0 |
| Male | 18 |
| Race/Ethnicity, Customized(Participants) | BR55 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Black | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| White | 16 |
| Other | 0 |
| Weight(kg) | BR55 |
|---|---|
| Mean | 83.62 ± 15.573 |
| Height(cm) | BR55 |
|---|---|
| Mean | 172.6 ± 8.71 |
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Bracco Diagnostics, Inc