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A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer

NCT00992745 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-10-12

No results posted yet for this study

Summary

This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with 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.

Conditions

Interventions

DRUG

123-I-MIP-1072

Single 10 mCi intravenous injection

DRUG

111-In capromab pendetide

Single 5 mCi intravenous injection

DRUG

123-I-MIP-1072

Single 5 mCi intravenous injection

Sponsors & Collaborators

  • Molecular Insight Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Dobkin, MD · Pacific Coast Imaging

  • Stanley Goldsmith, MD · NY Presbyterian Hospital - Weill Cornell Medical Center

  • Edward Coleman, MD · Duke University

  • Arif Hussain, MD · University of Maryland

  • Mack Roach, MD · University of California, San Francisco

  • Kevin Slawin, MD · Vanguard Urologic Research Foundation

  • Samuel L Kipper, MD · West Coast Radiology Centerse

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992745 on ClinicalTrials.gov