A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To further evaluate the safety of 123I-MIP-1072 [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: Yes ]
- To evaluate the intensity of 123I-MIP-1072 uptake with respect to Gleason Grade [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]
- To evaluate the intensity of 123I-MIP-1072 uptake with respect to PSMA expression [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]
- To evaluate feasibility of imaging123I-MIP-1072 uptake using an FDA-approved compact endorectal gamma camera probe (CGCP) [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Prostate Cancer Patients
Male participants who are scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center and have evidence of a recent (within 12 months of study entry) trans-rectal biopsy documenting adenocarcinoma of the prostate.
Single IV dose
Other Name: Trofex
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.
|United States, Maryland|
|CCR/NCI - Molecular Imaging Program|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter Choyke, MD||National Cancer Institute (NCI)|