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Trial: NCT01667536 [RDF]

Label NCT01667536
Slug nct01667536
Trialid NCT01667536
Lookup name NCT01667536
Lastchanged date December 14, 2016
Firstreceived results date December 15, 2015
Firstreceived date August 13, 2012
Id info nct id NCT01667536
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 105
Number of arms 1
Is section 801
Is fda regulated
Brief title A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
Official title 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
Study type Interventional
Id info nct alias
Completion date December 2013
Verification date December 2016
Why stopped
Id info org study id MIP-1404-201
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Study design
Source Molecular Insight Pharmaceuticals, Inc.
Primary completion date December 2013
Brief summary
Number of groups
Required header download date processed this data on January 09, 2018
Phase Phase 2
Start date August 2012
Has expanded access No
Biospec descr
Detailed description This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Condition browse None
Intervention browse None
Responsible party None
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Sponsor group None
Oversight info None
Eligibility None
Keywords None
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Locations None
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Location countries None
Interventions None
Secondary outcomes None
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Primary outcomes None
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Overall officials None