Status:
WITHDRAWN
LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Lead Sponsor:
Washington University School of Medicine
Conditions:
Pancreatic Cancer
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 cond...
Eligibility Criteria
Inclusion
- Newly diagnosed patients with gastrointestinal cancers, including pancreas, liver, gastric cancer, gastrointestinal stromal tumors, and metastatic cancers undergoing surgical resection as standard of care treatment.
- At least 18 years of age.
- For the first cohort of patients enrolled, must have an ECG with no prolonged intervals.
- Able to understand and willing to sign a written informed consent document.
Exclusion
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. We do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counterions.
- Presence of underlying lung disease.
- Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
- Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04105062
Start Date
December 31 2021
End Date
December 31 2023
Last Update
December 9 2021
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