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

NCT ID: NCT04105062

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Liver Cancer Gastric Cancer Gastrointestinal Stromal Cancer Metastatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers
The operating surgeon will remain blinded to the fluorescence images throughout the operation.

Study Groups

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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.

Group Type EXPERIMENTAL

LS301

Intervention Type DRUG

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

Cancer Vision Goggles

Intervention Type DEVICE

-Non-significant risk device

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.

Group Type EXPERIMENTAL

LS301

Intervention Type DRUG

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

Cancer Vision Goggles

Intervention Type DEVICE

-Non-significant risk device

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.

Group Type EXPERIMENTAL

LS301

Intervention Type DRUG

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

Cancer Vision Goggles

Intervention Type DEVICE

-Non-significant risk device

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.

Group Type EXPERIMENTAL

LS301

Intervention Type DRUG

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

Cancer Vision Goggles

Intervention Type DEVICE

-Non-significant risk device

Interventions

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LS301

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

Intervention Type DRUG

Cancer Vision Goggles

-Non-significant risk device

Intervention Type DEVICE

Other Intervention Names

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CVG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan C Fields, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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201911165

Identifier Type: -

Identifier Source: org_study_id