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

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.

Conditions

• Prostate Cancer

Interventions

DRUG

Drug: 99mTc-MIP-1404

A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Douglas Scherr, M.D. · New York Presbyterian Hospital-Cornell

• Jeffrey Karnes, MD · Mayo Clinic

• Kevin Slawin, MD · University of Texas Vanguard Urologic Research Foundation

• Thomas Keane, MD · Medical University of South Carolina

• Edouard Trabulsi, MD · Thomas Jefferson University / Jefferson Urology Associates

• David Jarrard, MD · University of Wisconsin, Madison

• William Ellis, MD · University of Washington

• Judd Moul, MD · Duke University

• Eric Klein, MD · Glickman Urology & Kidney Institute, Cleveland Clinic

• Bertram Yuh, MD · City of Hope National Cancer Center

• Steven Joniau, MD · Universitaire Ziekenhuizen KU Leuven

• Alberto Briganti, MD · Vita-Salute University San Raffaele

• Paolo Gontero, MD · University of Turin, Italy

• Mikhail I Shkolnik, MD · Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care

• Petr A Karlov, MD · St. Petersburg State Public Medical Institution: "Clinical Oncological Center"

• Vsevolod B Matveev, MD · Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"

• Boris Ya Alexeev, MD · Moscow Oncology Research Institute n.a. P.A. Hertsen

• Sergey V Mishugin, MD · City Clinical Hospital # 57

• Oleg B Karyakin · Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation

• Alexander K Nosov, MD · Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development

• Sergey B Petrov, MD · 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

• Milan Hora, MD, PhD · University Hospital Plzen, Department of Urology

• Josef Stolz, MD · University Hospital Motol, Clinic of Urology

• Vladimir Student, MD, PhD · University Hospital Olomouc, Clinic of Urology

• Marek Krolupper, MD · Hospital Na Bulovce, Department of Urology

• Michael Pesl,, MD · General University Hospital in Prague, Clinic of Urology

• Roman Zachoval,, MD, PhD, MBA · Thomayer's Hospital

• Marcin Matuszewski, MD, PhD · University Clinical Centre, Department of Urology

• Henryk Zielinski, MD · University Hospital Plzen, Department of Urology

• Jerzy Sokolowski, MD, PhD · Provincial Specialist Hospital in Wroclaw, Department of Urology

• Tomasz Szydelko, MD, PhD · 4th Military Teaching Hospital and Polyclinic,

• Geza Boszormenyi-Nagy, MD · Bajcsy-Zsilinszky Hospital, Department of Urology

• Peter Tenke, MD · Jahn Ferenc South Pest Hospital, Department of Urology

• Istvan Buzogany, MD · Peterfy Sandor Street Hospital, Department of Urology

• Michiel Sedelaar, MD · UMC St. Radboud Nijmegen

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States
• Belgium
• Czechia
• Hungary
• Italy
• Netherlands
• Poland
• Russia

Study Locations