15
Participants
Start Date
June 30, 2008
Primary Completion Date
August 31, 2010
Study Completion Date
November 30, 2010
UltratraceTM Iobenguane I 131 Imaging
0.1 mCi/kg \[3.7 MBq/kg\] (minimum dose 1mCi \[37MBq\] but not to exceed 5 mCi \[185 MBq\]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must be started prior to the Ultratrace imaging dose. Anterior and posterior whole body images will be taken to assess organ distribution, tumor uptake and dosimetry calculations.
UltratraceTM Iobenguane I 131 Therapy
Therapeutic dose will be given on Day 0 if dosimetry scans showed that the prescribed or adjusted dose will not exceed \> 23 Gy to the kidneys, \> 30 Gy to the liver, or \> 15 Gy to the lungs. and tumor uptake confirmed with UltratraceTM imaging dose. Only one treatment course of therapeutic UltratraceTM will be given in this study.
University of Chicago Comer Children's Hospital, Chicago
Texas Children's Hospital, Houston
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto
Childrens Hospital Los Angeles, Los Angeles
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor
Cincinnati Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia, Philadelphia
Lead Sponsor
Molecular Insight Pharmaceuticals, Inc.
INDUSTRY