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Brief Title: A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
Official Title: A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
Study ID: NCT00992745
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
West Coast Radiology Centers, Laguna Niguel, California, United States
Pacific Coast Imaging, Newport Beach, California, United States
University of California - San Francisco, San Francisco, California, United States
University of Maryland, Baltimore, Maryland, United States
New York Presbyterian Hospital - Weill Cornell Medical College, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Vanguard Urologic Research Foundation, Houston, Texas, United States
Name: Jeffrey Dobkin, MD
Affiliation: Pacific Coast Imaging
Role: PRINCIPAL_INVESTIGATOR
Name: Stanley Goldsmith, MD
Affiliation: NY Presbyterian Hospital - Weill Cornell Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Edward Coleman, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Arif Hussain, MD
Affiliation: University of Maryland
Role: PRINCIPAL_INVESTIGATOR
Name: Mack Roach, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
Name: Kevin Slawin, MD
Affiliation: Vanguard Urologic Research Foundation
Role: PRINCIPAL_INVESTIGATOR
Name: Samuel L Kipper, MD
Affiliation: West Coast Radiology Centerse
Role: PRINCIPAL_INVESTIGATOR