NCT01279785

A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

A Phase 1 Pilot Study of 123I-MIP-1072 Single Photon Emission Computed Tomography (SPECT)/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.

Detailed description

This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072 intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with histological confirmation of disease localization and staging. Methodical evaluation of 123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based. The optional additional CGCP imaging was added, because of its inherent potential for higher resolution scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will provide important preliminary information for the use of CGCP imaging in prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	123I-MIP-1072	Single IV dose

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-01-19
• Last updated: 2015-11-25

Locations

1 site across 1 country: United States