Clinical trial · Interventional
A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
NCT02142608CI-TRIAL-00050928completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR55 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BR55
- description
- All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
- interventionNames
- Drug: BR55
Primary outcomes (1)
- measure
- Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
- timeFrame
- Within 30 minutes after administration of BR55
- description
- To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Secondary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 24 hours post-dose
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male, age between 50-70 years old * Increased Prostate-Specific Antigen (PSA) level \>4 ng/mL * Known prostate cancer * Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable) * Provided written informed consent and willing to comply with protocol requirements Exclusion Criteria: * Documented acute prostatitis or urinary tract infections * Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease * History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts * Severe cardiac rhythm disorders within the last 7 days * Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome * Received a prostate biopsy procedure within 30 days before admission into the study * Determined by investigator to be clinically unsuitable for the study * Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
References
Publications (0)
Data not yet available
No reference posted for this study.