Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor
imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give
written, informed consent and meet all inclusion criteria and no exclusion criteria, and
whose laboratory results are within specified limits at the screening visit, will be
enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650.
Study subjects will have whole body PET/CT imaging at three different timepoints with all
patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects
will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to
26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity
distribution will be measured.
Intervention Model: Single Group Assignment, Masking: Open Label
To estimate the intensity and distribution in critical and non-critical organs.
United States: Institutional Review Board
|City of Hope National Medical Center||Los Angeles, California 91010|
|University of Arkansas||Little Rock, Arkansas 72202|
|Washington University School of Medicine, Siteman Cancer Center||St. Louis, Missouri 63110|
|John Hopkins University||Baltimore, Maryland 21231|