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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 ID: NCT01667536
Brief Summary: This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.
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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
City of Hope National Cancer Center, Duarte, California, United States
Mayo Clinic, Rochester, Minnesota, United States
New York Presbyterian Hospital - Cornell, New York City, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Glickman Urology & Kidney Institute, Cleveland Clinic, Cleveland, Ohio, United States
Thomas Jefferson University / Jefferson Urology Associates, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
University of Texas Vanguard Urologic Research Foundation, Houston, Texas, United States
University of Washington School of Medicine, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
University Hospitals Leuven, Leuven, , Belgium
University Hospital Olomouc, Clinic of Urology, Olomouc, , Czech Republic
University Hospital Plzen, Department of Urology, Plzen, , Czech Republic
General University Hospital in Prague, Clinic of Urology, Prague, , Czech Republic
Thomayer's Hospital, Prague, , Czech Republic
University Hospital Motol, Clinic of Urology, Prague, , Czech Republic
Hospital Na Bulovce, Department of Urology, Prague, , Czech Republic
Bajcsy-Zsilinszky Hospital, Department of Urology, Budapest, , Hungary
Peterfy Sandor Street Hospital, Department of Urology, Budapest, , Hungary
Jahn Ferenc South Pest Hospital, Department of Urology, Budapest, , Hungary
Vita-Salute University San Raffaele, Milan, , Italy
University of Turin, Torino, , Italy
UMC St. Radboud Nijmegen, Nijmegen, , Netherlands
University Clinical Centre, Department of Urology, Gdansk, , Poland
University Hospital Plzen, Department of Urology, Warsaw, , Poland
4th Military Teaching Hospital and Polyclinic,, Wroclaw, , Poland
"Provincial Specialist Hospital in Wroclaw, Department of Urology, Wroclaw, , Poland
City Clinical Hospital # 57, Moscow, , Russian Federation
Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences", Moscow, , Russian Federation
Moscow Oncology Research Institute n.a. P.A. Hertsen, Moscow, , Russian Federation
Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation, Obninsk, , Russian Federation
All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters, Saint-Petersburg, , Russian Federation
Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care, Saint-Petersburg, , Russian Federation
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development, Saint-Petersburg, , Russian Federation
St. Petersburg State Public Medical Institution: "Clinical Oncological Center", Saint-Petersburg, , Russian Federation
Name: Douglas Scherr, M.D.
Affiliation: New York Presbyterian Hospital-Cornell
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Karnes, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Kevin Slawin, MD
Affiliation: University of Texas Vanguard Urologic Research Foundation
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Keane, MD
Affiliation: Medical University of South Carolina
Role: PRINCIPAL_INVESTIGATOR
Name: Edouard Trabulsi, MD
Affiliation: Thomas Jefferson University / Jefferson Urology Associates
Role: PRINCIPAL_INVESTIGATOR
Name: David Jarrard, MD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR
Name: William Ellis, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
Name: Judd Moul, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Klein, MD
Affiliation: Glickman Urology & Kidney Institute, Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Bertram Yuh, MD
Affiliation: City of Hope National Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Joniau, MD
Affiliation: Universitaire Ziekenhuizen KU Leuven
Role: PRINCIPAL_INVESTIGATOR
Name: Alberto Briganti, MD
Affiliation: Vita-Salute University San Raffaele
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Gontero, MD
Affiliation: University of Turin, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Mikhail I Shkolnik, MD
Affiliation: Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
Role: PRINCIPAL_INVESTIGATOR
Name: Petr A Karlov, MD
Affiliation: St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
Role: PRINCIPAL_INVESTIGATOR
Name: Vsevolod B Matveev, MD
Affiliation: Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
Role: PRINCIPAL_INVESTIGATOR
Name: Boris Ya Alexeev, MD
Affiliation: Moscow Oncology Research Institute n.a. P.A. Hertsen
Role: PRINCIPAL_INVESTIGATOR
Name: Sergey V Mishugin, MD
Affiliation: City Clinical Hospital # 57
Role: PRINCIPAL_INVESTIGATOR
Name: Oleg B Karyakin
Affiliation: Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander K Nosov, MD
Affiliation: Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
Role: PRINCIPAL_INVESTIGATOR
Name: Sergey B Petrov, MD
Affiliation: All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters
Role: PRINCIPAL_INVESTIGATOR
Name: Milan Hora, MD, PhD
Affiliation: University Hospital Plzen, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Josef Stolz, MD
Affiliation: University Hospital Motol, Clinic of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Vladimir Student, MD, PhD
Affiliation: University Hospital Olomouc, Clinic of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Marek Krolupper, MD
Affiliation: Hospital Na Bulovce, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Pesl,, MD
Affiliation: General University Hospital in Prague, Clinic of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Roman Zachoval,, MD, PhD, MBA
Affiliation: Thomayer's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Marcin Matuszewski, MD, PhD
Affiliation: University Clinical Centre, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Henryk Zielinski, MD
Affiliation: University Hospital Plzen, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Jerzy Sokolowski, MD, PhD
Affiliation: Provincial Specialist Hospital in Wroclaw, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Tomasz Szydelko, MD, PhD
Affiliation: 4th Military Teaching Hospital and Polyclinic,
Role: PRINCIPAL_INVESTIGATOR
Name: Geza Boszormenyi-Nagy, MD
Affiliation: Bajcsy-Zsilinszky Hospital, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Tenke, MD
Affiliation: Jahn Ferenc South Pest Hospital, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Istvan Buzogany, MD
Affiliation: Peterfy Sandor Street Hospital, Department of Urology
Role: PRINCIPAL_INVESTIGATOR
Name: Michiel Sedelaar, MD
Affiliation: UMC St. Radboud Nijmegen
Role: PRINCIPAL_INVESTIGATOR