NCT01667536

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-08-17
• Last updated: 2017-02-07
• Results posted: 2016-03-30

Locations

35 sites across 8 countries: United States, Belgium, Czechia, Hungary, Italy, Netherlands, Poland, Russia