drugset / Trial / NCT02840552

The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer

NCT02840552

Phase 3 Completed 60 enrolled Sir Mortimer B. Davis - Jewish General Hospital
NaSingle-groupOpen-labelDiagnostic

Summary

The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.

Timeline

Start
2016-09
Primary completion
2018-02
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject fluorocholine Diagnostic / imaging agent

Indications