This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.
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.
Study Type
OBSERVATIONAL
Single IV dose
CCR/NCI - Molecular Imaging Program
Bethesda, Maryland, United States
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
Time frame: Evaulated through Day 30
To evaluate the potential of 123I-MIP-1072 imaging to predict malignancy as defined by histopathology and multiparametric 3T MR
Time frame: Evaulated through Day 30
To further evaluate the safety of 123I-MIP-1072
Time frame: Evaluated through Day 30
To evaluate the intensity of 123I-MIP-1072 uptake with respect to Gleason Grade
Time frame: Evaluated through Day 30
To evaluate the intensity of 123I-MIP-1072 uptake with respect to PSMA expression
Time frame: Evaluated through Day 30
To evaluate feasibility of imaging123I-MIP-1072 uptake using an FDA-approved compact endorectal gamma camera probe (CGCP)
Time frame: Evaluated through Day 30
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