LS301 Uptake In Tumors Of Patients Undergoing Liver, Pancreas, Or Gastric Surgery

Study Overview

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.

N/A

Pancreatic Cancer
Liver Cancer
Gastric Cancer
Gastrointestinal Stromal Cancer
Metastatic Cancer

DRUG: LS301
DEVICE: Cancer Vision Goggles

201911165

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-12-01
First Submitted that Met QC Criteria 2019-09-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-12-09
First Posted (ACTUAL) 2019-09-26	Results First Posted N/A	Last Verified 2021-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
Single

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

Primary Outcome Measures	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)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Ryan C Fields, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record