A Phase 1 Pilot Study of 123I-MIP-1072 Single Photon Emission Computed Tomography (SPECT)/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072
intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with
histological confirmation of disease localization and staging. Methodical evaluation of
123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important
preliminary data upon which further clinical studies can be based. The optional additional
CGCP imaging was added, because of its inherent potential for higher resolution
scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will
provide important preliminary information for the use of CGCP imaging in prostate cancer.
Observational
Observational Model: Cohort, Time Perspective: Prospective
To evaluate the tissue distribution of 123I-MIP-1072 SPEC/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
Evaulated through Day 30
No
Peter Choyke, MD
Principal Investigator
National Cancer Institute (NCI)
United States: Food and Drug Administration
TX-P104
NCT01279785
March 2011
October 2011
Name | Location |
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CCR/NCI - Molecular Imaging Program | Bethesda, Maryland 20892 |