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

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

Drug: 99mTc-MIP-1404

Douglas Scherr, M.D.

Jeffrey Karnes, MD

Kevin Slawin, MD

Thomas Keane, MD

Edouard Trabulsi, MD

David Jarrard, MD

William Ellis, MD

Judd Moul, MD

Eric Klein, MD

Bertram Yuh, MD

Steven Joniau, MD

Alberto Briganti, MD

Paolo Gontero, MD

Mikhail I Shkolnik, MD

Petr A Karlov, MD

Vsevolod B Matveev, MD

Boris Ya Alexeev, MD

Sergey V Mishugin, MD

Oleg B Karyakin

Alexander K Nosov, MD

Sergey B Petrov, MD

Milan Hora, MD, PhD

Josef Stolz, MD

Vladimir Student, MD, PhD

Marek Krolupper, MD

Michael Pesl,, MD

Roman Zachoval,, MD, PhD, MBA

Marcin Matuszewski, MD, PhD

Henryk Zielinski, MD

Jerzy Sokolowski, MD, PhD

Tomasz Szydelko, MD, PhD

Geza Boszormenyi-Nagy, MD

Peter Tenke, MD

Istvan Buzogany, MD

Michiel Sedelaar, MD

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.

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.

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

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

For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.

For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.

Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.

Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.

Molecular Insight Pharmaceuticals, Inc.

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

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

Age, Continuous

Gender

Senior Director, Clinical Science Communications

The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)

Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.

The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.

Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes

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

Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland

Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions

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

Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging.

Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.

Drug: 99mTc-MIP-1404 + MRI

All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.

Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.

All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology	NCT01667536	Prostate Cancer	Drug: 99mTc-MIP...	21 Years -	Molecular Insight Pharmaceuticals, Inc.
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology	NCT01667536	Prostate Cancer	Drug: 99mTc-MIP...	21 Years -	Molecular Insight Pharmaceuticals, Inc.

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