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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04105062
• Other study ID #: 201911165
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• LS301
-LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine

Device:
• Cancer Vision Goggles
-Non-significant risk device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient	Safety evaluation includes vital signs, clinical laboratory testing and ECG, measured pre- (within 10-15 minutes or 30 minutes of injection) and post-injection (within 30 minutes or/and at ~60 minutes).; Adverse events will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	From time of injection to 1 hour post-injection
Primary	Phase I only: Optimal imaging dose of LS301	The optimal will be the dose at which fewer than 2 dose-limiting toxicities (DLTs) are observed and optimal image quality is observed. It need not be the maximum tolerated dose (MTD) if optimal image quality is observed at a lower dose than the MTD; DLT is defined as any grade 2 or above toxicity that occurs during the hour after injection that is considered possibly, probably, or definitely related to LS301.	From time of injection to 1 hour post-injection
Primary	Phase II only: Ability of LS301 to predict presence of positive margins	Margin status called by LS301 and CVG will be compared to the gold standard histopathological results; The histopathological results of margin positivity has the following possible results: margin negative, margin positive at LS301 and CVG identified locations, margin positive at LS301 and CVG unidentified locations. Using LS301 and CVG, the exercised tissue will be considered to be margin positive and have ink marked at the identified locations if any positive margins are observed; otherwise, the margin is considered negative.	At the time of pathological analysis (within 2-3 days of surgery)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine