drugset / Trial / NCT04838626

Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection

NCT04838626

Phase 2/3 Completed 195 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelDiagnostic

Summary

The purpose of this study was 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) were used for the histopathology assessments.

Timeline

Start
2021-09-07
Primary completion
2023-11-24
Completion
2023-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject [18F]CTT1057 Diagnostic / imaging agent 370 mbq Intravenous

Indications