Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
Status:
Recruiting
Trial end date:
2023-02-24
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET
imaging agent for detection and localization of PSMA positive tumors using histopathology as
Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes
dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa)
will be used for the histopathology assessments.
Approximately 195 participants will be enrolled to ensure that at least 156 participants
complete the [18F]CTT1057 PET/CT scan procedure (i.e. investigational imaging agent
administration and successful completion of the PET/CT scan), which will be required for the
calculation of the co-primary endpoints.