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Study Comparing 123-I-MIP-1072 to ProstaScint® in Patients With Recurrent Metastatic Prostate Cancer

2014-08-27 03:18:46 | BioPortfolio

Summary

This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide) for the detection of prostate cancer lesions in patients with recurrent metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Prostate Cancer

Intervention

123-I-MIP-1072, 111-In capromab pendetide

Location

Pacific Coast Imaging
Irvine
California
United States
92604

Status

Recruiting

Source

Molecular Insight Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:46-0400

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Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

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