EXPLORATORY CLINICAL TRIAL USING BR55 TARGETED ULTRASOUND CONTRAST AGENT IN THE DETECTION OF PROSTATE CANCER BY MOLECULAR IMAGING OF VEGFR2 - BR55 in prostate cancer: an exploratory clinical trial

Bracco Imaging S.p.A0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•* 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

•* 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;

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