focal prostate lesion prostate cancer
Conditions
Interventions
all enrolled patients will receive the BR55 contrast agent.1) The dose(s) of
0.01 mL/kg (dose A) and 0.02 mL/kg (dose B) (in case of no enhancement detected
with the dose A) of BR55 will be used for
Sponsors
Bracco Imaging S.p.A
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male patient, age * 40 years old * Has a histology proven focal prostate cancer lesion * The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration * Provides written Informed Consent and is willing to comply with protocol requirements
Exclusion criteria
Exclusion criteria: * Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100*g) according to the indication of the EMEA guideline M3 for this type of study * Has documented acute prostatitis or urinary tract infections * With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts * Has had severe cardiac rhythm disorders within the last 7 days * Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome * Has received a prostate biopsy procedure within 30 days before admission into this study * Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study. * Is determined by the Investigator that the patient is clinically unsuitable for the study. * Is incapable of understanding the language in which the information for the patient is given * Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A - Contrast enhancement scores: 0. No enhancement: No contrast enhancement is detected within the target lesion 1. Slight enhancement: Presence of minimal BR55 contrast enhancement in the target lesion 2. Moderate enhancement: Presence of moderate BR55 contrast enhancement in the target lesion 3. Strong enhancement: Presence of strong BR55 contrast enhancement in the target lesion. B - Histopathology and Immunohistochemistry assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Same as primary | — |
Countries
Netherlands
Outcome results
None listed