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Trial: NCT01667536 [RDF]

Label NCT01667536
Slug nct01667536
Trialid NCT01667536
Lookup name NCT01667536
Provenance http://clinicaltrials.gov/show/NCT01667536?displayxml=true
Lastchanged date February 29, 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 ClinicalTrials.gov record.
Enrollment 105
Number of arms 1
Is section 801 Yes
Is fda regulated Yes
Brief title A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
Acronym
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 February 2016
Why stopped
Id info org study id MIP-1404-201
Required header url https://clinicaltrials.gov/show/NCT01667536
Study design Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Source Molecular Insight Pharmaceuticals, Inc.
Primary completion date December 2013
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on October 21, 2016
Phase Phase 2
Start date August 2012
Has expanded access No
Biospec descr
Detailed description
Condition browse None
Intervention browse None
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group None
Oversight info None
Eligibility None
Keywords High Risk, Newly diagnosed, prostate cancer, PROSTATECTOMY SURGERY
Conditions Prostate Cancer
Locations 0476e2c8cc8afff95f7e045f32739960, 155300493ae13910e08dea0048ab01d7, 18d3b00578e46624091e324e34a8fda7 More →
Links None
Results references None
Arm groups Drug: 99mTc-MIP-1404 (Arm Group)
Location countries Belgium, Czech Republic, Hungary, Italy, Netherlands, Poland, Russian Federation, United States
Interventions Drug: 99mTc-MIP-1404 (Intervention)
Secondary outcomes 96596c3eda97df41e3f969a92ae8d249
References 5cb00cb730c8ef2221282c6c5159877e
Primary outcomes None
Removed countries None
Overall officials None