drugset / Trial / NCT04105062

LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery

NCT04105062 ↗

Non-randomizedSequentialSingle-blindDiagnostic

Summary

The preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the Cancer Vision Googles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 15% in pancreatic cancer, for example. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.

Timeline

Start
2021-12-31
Primary completion
2023-12-31
Completion
2023-12-31

Outcome

Outcome not reported

Stopped: “One of the investigators is leaving the University.”

Drugs

EvaluationDrugModalityDoseRoute
Subject LS301-IT Diagnostic / imaging agent 0.05 mg/kg Intravenous
Subject LS301-IT Diagnostic / imaging agent 0.075 mg/kg Intravenous
Subject LS301-IT Diagnostic / imaging agent 0.1 mg/kg Intravenous