A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Molecular Insight Pharmaceuticals, Inc0 个研究点目标入组 100 人开始时间: 2012年6月25日最近更新: 2013年12月9日

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•Subjects must meet all of the following criteria to be enrolled in this study:
•1. Male aged 21 years or older.
•2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
•3. Biopsy confirmed presence of adenocarcinoma of the prostate gland.
•4. At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130
•5. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
•6. Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc-MIP-1404 injection
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Subjects must not meet any of the following criteria to be enrolled in this study:
•1. Participating would significantly delay the scheduled standard of care therapy.
•2. Administered a radioisotope within 5 physical half lives prior to study drug injection.
•3. Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
•4. Have a contraindication for MR imaging.

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