Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105062
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Liver Cancer Gastric Cancer Gastrointestinal Stromal Cancer Metastatic Cancer Drug: LS301 Device: Cancer Vision Goggles Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Single (Care Provider)
Masking Description: The operating surgeon will remain blinded to the fluorescence images throughout the operation.
Primary Purpose: Diagnostic
Official Title: Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: CVG




Primary Outcome Measures :
  1. Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient [ Time Frame: From time of injection to 1 hour post-injection ]
    • 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

  2. Phase I only: Optimal imaging dose of LS301 [ Time Frame: From time of injection to 1 hour post-injection ]
    • 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.

  3. Phase II only: Ability of LS301 to predict presence of positive margins [ Time Frame: At the time of pathological analysis (within 2-3 days of surgery) ]
    • 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105062


Contacts
Layout table for location contacts
Contact: Ryan C Fields, M.D. 314-286-1694 rcfields@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Ryan C Fields, M.D.    314-286-1694    rcfields@wustl.edu   
Principal Investigator: Ryan C Fields, M.D.         
Sub-Investigator: Samuel Achilefu, Ph.D.         
Sub-Investigator: Will Chapman, M.D.         
Sub-Investigator: Deyali Chatterjee, M.D.         
Sub-Investigator: MB Majella Doyle, M.D.         
Sub-Investigator: Farrokh Dehdashti, M.D.         
Sub-Investigator: Chet Hammill, M.D.         
Sub-Investigator: William Hawkins, M.D.         
Sub-Investigator: Adeel Khan, M.D.         
Sub-Investigator: Esther Lu, Ph.D.         
Sub-Investigator: Dominic Sanford, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Ryan C Fields, M.D. Washington University School of Medicine

Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04105062    
Other Study ID Numbers: 201911165
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancrelipase
Gastrointestinal Agents