In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.
The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Johns Hopkins University
Baltimore, Maryland, United States
Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline
Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.
Time frame: Change from baseline to up to 4 weeks
Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.
Time frame: 3 years
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