74
Participants
Start Date
June 4, 2009
Primary Completion Date
February 14, 2017
Study Completion Date
February 28, 2021
Ultratrace® Iobenguane I131
Each subject will be administered 3 mCi to 6 mCi Ultratrace® Iobenguane I 131, referred to as the Imaging Dose, to confirm that subject meets radiological entry criteria and to establish dosimetry. All subjects meeting entry criteria will then receive the investigational product referred to as the Therapeutic Dose (500 mCi or 8 mCi/kg if the subject weighs 62.5 kg or less) of Ultratrace Iobenguane I 131, followed by imaging at 7 days post infusion or upon discharge from isolation. The Therapeutic Doses will be adjusted equally if warranted by results of the dosimetry evaluation. At least 3 months later, subjects will receive the second Therapeutic Dose.
Mount Sinai School of Medicine, New York
Hospital of the University of Pennsylvania, Philadelphia
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
University of Miami Miller School of Medicine, Miami
University of Iowa, Iowa City
Washington University School of Medicine, Alvin J. Siteman Cancer Center, St Louis
MD Anderson Cancer Center, Houston
University of California-San Francisco, San Francisco
Rhode Island Hospital, Providence
Lead Sponsor
Molecular Insight Pharmaceuticals, Inc.
INDUSTRY