drugset / Trial / NCT06434909

CYTALUX™for the Intraoperative Imaging of Prostate Cancer

NCT06434909 ↗

NaSingle-groupOpen-labelDiagnostic

Summary

This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)

Timeline

Start
2024-09-19
Primary completion
2025-09-04
Completion
2025-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject pafolacianine Diagnostic / imaging agent — Intravenous

Indications