Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
IV injection followed by PET/CT scanning
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, United States
Sensitivity of Ga-68-P16-093 in BCR
We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.
Time frame: 2 weeks
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Time frame: 4 months
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from \~ 5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames.
Time frame: 2-60 days following PET/CT scan
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