LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Cancer
- Gastrointestinal Stromal Cancer
- Liver Cancer
- Metastatic Cancer
- Pancreatic Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A rolling six design will be used to enroll patients in the phase 1 dose escalating portion of the study, during which LS301 will be administered intravenously at one of three doses. After the optimal dose has been determined, an additional 9 patients will be enrolled in the phase I expansion cohort to evaluate for safety. The optimal imaging dose of LS301 determined in phase I will be administered in 88 patients in the phase II portion of the study.Masking: Single (Care Provider)Masking Description: The operating surgeon will remain blinded to the fluorescence images throughout the operation.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04105062
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ryan C Fields, M.D. Washington University School of Medicine
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