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Spots Global Cancer Trial Database for A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

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Trial Identification

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

Conditions

Prostate Cancer

Study Description

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.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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