EUCTR2012-001864-30-BE
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer within prostate gland and metastatic prostate cancer in regional lymph nodes
- Sponsor
- Molecular Insight Pharmaceuticals, Inc
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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