NCT04105062

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Liver Cancer
• Gastric Cancer
• Gastrointestinal Stromal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	LS301	-LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine
DEVICE	Cancer Vision Goggles	-Non-significant risk device

Timeline

• Start date: 2021-12-31
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-09-26
• Last updated: 2021-12-09

Regulatory

• FDA-regulated drug study
• FDA-regulated device study