Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01667536 | A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology | PHASE2 | COMPLETED | 105 | — | — | Aug 1, 2012 | Dec 1, 2013 | Feb 7, 2017 | 35 | United States, Belgium +6 |
For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
| Arm | Type | Description |
|---|---|---|
| Drug: 99mTc-MIP-1404 | EXPERIMENTAL | 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 |
| Name | Type | Description |
|---|---|---|
| Drug: 99mTc-MIP-1404 | DRUG | A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 |
Inclusion Criteria: * Male aged 21 years or older. * Ability to provide signed informed consent and willingness to comply with protocol requirements. * Biopsy confirmed presence of adenocarcinoma of the prostate gland. * At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogra...