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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastric Cancer; Pancreatic Cancer; Metastatic Cancer; Liver Cancer; Gastrointestinal Stromal Cancer
• Intervention / Treatment: Drug: LS301; Device: Cancer Vision Goggles

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phase I: LS301 Dose Level 1 (0.05 mg/kg); The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.; The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.; The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence.	Drug: LS301; -LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine; Device: Cancer Vision Goggles; -Non-significant risk device; Other Names: CVG
EXPERIMENTAL: Phase I: LS301 Dose Level 2 (0.075 mg/kg); The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.; The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.; The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence.	Drug: LS301; -LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine; Device: Cancer Vision Goggles; -Non-significant risk device; Other Names: CVG
EXPERIMENTAL: Phase I: LS301 Dose Level 3 (0.1 mg/kg); The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.; The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.; The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence.	Drug: LS301; -LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine; Device: Cancer Vision Goggles; -Non-significant risk device; Other Names: CVG
EXPERIMENTAL: Phase II: LS301 Dose determined in Phase I; The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.; The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.; The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence.	Drug: LS301; -LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine; Device: Cancer Vision Goggles; -Non-significant risk device; Other Names: CVG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 31, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 201911165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No