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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

Study:

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

Rationale:

n/a

Purpose:

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.

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Prostate Cancer Drug: Drug: 99mTc-MIP-1404 Phase 2

Verified by Molecular Insight Pharmaceuticals, Inc. November, 2013

Sponsored by: Molecular Insight Pharmaceuticals, Inc.
Information provided by: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov identifier: NCT01667536

Study Type: Interventional

Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Glickman Urology & Kidney Institute, Cleveland Clinic
Cleveland, Ohio 44195
United States

Douglas Scherr, M.D.., Principal Investigator
Jeffrey Karnes, MD., Principal Investigator
Kevin Slawin, MD., Principal Investigator
Thomas Keane, MD., Principal Investigator
Edouard Trabulsi, MD., Principal Investigator
David Jarrard, MD., Principal Investigator
William Ellis, MD., Principal Investigator
Judd Moul, MD., Principal Investigator
Eric Klein, MD., Principal Investigator
Bertram Yuh, MD., Principal Investigator
Steven Joniau, MD., Principal Investigator
Alberto Briganti, MD., Principal Investigator
Paolo Gontero, MD., Principal Investigator
Mikhail I Shkolnik, MD., Principal Investigator
Petr A Karlov, MD., Principal Investigator
Vsevolod B Matveev, MD., Principal Investigator
Boris Ya Alexeev, MD., Principal Investigator
Sergey V Mishugin, MD., Principal Investigator
Oleg B Karyakin., Principal Investigator
Alexander K Nosov, MD., Principal Investigator
Sergey B Petrov, MD., Principal Investigator
Milan Hora, MD, PhD., Principal Investigator
Josef Stolz, MD., Principal Investigator
Vladimir Student, MD, PhD., Principal Investigator
Marek Krolupper, MD., Principal Investigator
Michael Pesl,, MD., Principal Investigator
Roman Zachoval,, MD, PhD, MBA., Principal Investigator
Marcin Matuszewski, MD, PhD., Principal Investigator
Henryk Zielinski, MD., Principal Investigator
Jerzy Sokolowski, MD, PhD., Principal Investigator
Tomasz Szydelko, MD, PhD., Principal Investigator
Geza Boszormenyi-Nagy, MD., Principal Investigator
Peter Tenke, MD., Principal Investigator
Istvan Buzogany, MD., Principal Investigator
Michiel Sedelaar, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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