Start Date
January 31, 2010
Primary Completion Date
October 31, 2011
Ultratrace Iobenguane I 131
Subjects will receive an Imaging Dose of 0.1 mCi/kg \[3.7 MBq/kg\] (a minimum dose of 1.0 mCi \[37 MBq\] but not to exceed 5.0 mCi \[185 MBq\]) of Ultratrace iobenguane I 131 to have dosimetry performed and to confirm tumor uptake of the test article prior to receiving each of 2 planned Therapeutic Doses of Ultratrace iobeneguane I 131 . Within 28 days of screening, eligible subjects (as confirmed by the first Imaging dose study)will receive an Ultratrace iobenguane I 131 Therapeutic dose of of 15.0 - 18.0 mCi/kg (max. 666 MBq/kg) followed by imaging 7 days later or upon discharge from radiation isolation. A second Therapeutic Dose (preceded by a repeat Image Dose and dosimetry study)and imaging upon discharge from radiation isolation will be repeated approximately 8 weeks after the first dose.
Mount Sinai School of Medicine, New York
Hospital - Weill Cornell Medical Center, New York
Memorial Sloan Kettering, New York
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
Medical University of South Carolina, Charleston
University of Miami Miller School of Medicine, Miami
Cincinnati Children's Hospital, Cincinnati
CS Motts Children's Hospital, Ann Arbor
University of iowa, Iowa City
University of Wisconsin Medical Center, Madison
Childrens Memorial/Northwestern University, Chicago
Comer's Childrens Hospital/University of Chicago, Chicago
Cook Children's Healthcare System, Fort Worth
MD Anderson Cancer Center, Houston
Texas Childrens Hospital Cancer Center, Houston
Children's Hospital of LA, Los Angeles
UCSF Pediatric Hematology/Oncology, San Francisco
Children's Hospital/Dana Farber Cancer Institute, Boston
The Hospital for Sick Children, Toronto
Lead Sponsor
Molecular Insight Pharmaceuticals, Inc.
INDUSTRY