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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02615067 | Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer | PHASE3 | COMPLETED | 531 | — | — | Dec 1, 2015 | Dec 28, 2017 | Apr 10, 2019 | 45 | United States, Canada |
| NCT01654874 | 99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404 | PHASE1 | COMPLETED | 6 | — | — | Jul 1, 2012 | - | Nov 25, 2015 | 1 | United States |
| NCT01615406 | A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer | PHASE1 | COMPLETED | 9 | — | — | Apr 1, 2012 | - | Nov 25, 2015 | 1 | United States |
| NCT01572701 | Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection | PHASE1 | COMPLETED | 8 | — | — | Jan 1, 2012 | - | Nov 25, 2015 | 1 | United States |
| NCT01261754 | A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers | PHASE1 | COMPLETED | 16 | — | — | Dec 1, 2010 | - | Nov 25, 2015 | 1 | United States |
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes (as determined by histopathology) in patients undergoing standard of care prostatectomy with or without extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
The safety data will be summarized for all patients receiving at least one dose of study drug. Summary tables, including change from pre dose to post dose where applicable, will be presented for the following safety endpoints: * Treatment emergent adverse events * Clinical Laboratory Evaluations * Physical examination, vital signs, and ECGs
Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism.
Percent of injected activity (%IA) in a set of source organs will be determined by comparing a reference whole body scan to subsequent whole body scans to determine percentage of administered activity for source organs at the various scanning times. This biodistribution data will then be used to mathematically model source organ residence times, which will be used to estimate radiation absorbed dose to target organs. Percent injected activity and estimated residence times will be summarized by organ.
| Arm | Type | Description |
|---|---|---|
| 99mTc-MIP-1404 Injection | EXPERIMENTAL | 20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404 |
| Preparation A | EXPERIMENTAL | 20 (±3) mCi 99mTc-MIP-1404 (preparation A) |
| Preparation B | EXPERIMENTAL | 20 (±3) mCi 99mTc-MIP-1404 (preparation B) |
| Drug: 99mTc-MIP-1404 | EXPERIMENTAL | 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404 |
| 20 (±3) mCi of study drug | EXPERIMENTAL | - |
| Metastatic prostate adenocarcinoma | ACTIVE_COMPARATOR | - |
| Healthy Volunteers | ACTIVE_COMPARATOR | - |
| Newly Diagnosed, High-Risk Prosate Cancer Patients | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 99mTc-MIP-1404 Injection | DRUG | A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404. |
| Whole-Body Planar and pelvic SPECT/CT scan | DIAGNOSTIC_TEST | A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404. |
| 99mTc-MIP-1404 | DRUG | - |
| 99mTc MIP 1404 | DRUG | A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404 |
| 99mTc MIP 1405 | RADIATION | Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405 |
INCLUSION CRITERIA: * Ability to provide informed consent and willingness to comply with protocol requirements * Life expectancy ≥ 6 months Cohort A only: * A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland * With...