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LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT02807597
Recruitment Status : Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (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 breast cancer patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 20%. 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
Breast Cancer Cancer of the Breast Other: LS301 Device: Cancer Vision Goggles Procedure: Surgery Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: LS301 Dose Escalation
  • Patient will undergo intravenous injection of the appropriate cohort dose of LS301 at least four hours before surgery (24 hours is the preferred time point wherever possible)
  • Starting dose level will be 100 µg/kg, dose level 2 will be 150 µg/kg, and dose level -1 will be 50 µg/kg
  • Before removing the tissues, the surgeon will determine the presence of NIR fluorescence in the tumor or SLN.
  • After removing the tumor tissue, the CVG will be used to assess LS301 fluorescence in the surgical margins, as well as the cavity where the tumor was removed.
Other: LS301
-LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond.

Device: Cancer Vision Goggles
-Surgeon will wear during surgery
Other Name: CVG

Procedure: Surgery
-Standard of care

Experimental: Arm 2: LS301 Dose Expansion
  • Patient will undergo intravenous injection of the appropriate cohort dose of LS301 at least four hours before surgery (24 hours is the preferred time point wherever possible)
  • Dose of LS301 will be based on the maximum tolerated dose found in the Dose Escalation arm
  • Before removing the tissues, the surgeon will determine the presence of NIR fluorescence in the tumor or SLN.
  • After removing the tumor tissue, the CVG will be used to assess LS301 fluorescence in the surgical margins, as well as the cavity where the tumor was removed.
Other: LS301
-LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond.

Device: Cancer Vision Goggles
-Surgeon will wear during surgery
Other Name: CVG

Procedure: Surgery
-Standard of care




Primary Outcome Measures :
  1. Safety of LS301 in breast as measured by adverse events (Dose Escalation only) [ Time Frame: Time of injection to 1 hour post-injection ]
    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  2. Selective retention of LS301 in breast cancer and positive sentinel lymph node (SLN) (Dose Expansion only) [ Time Frame: Day 1 (at the time of surgery) ]
    -Accuracy of selective LS301 uptake will be determined by comparison to histopathology.


Secondary Outcome Measures :
  1. Ability of LS301 to predict presence of positive margins around partial mastectomy specimens and positive SLNs as measured by the fluorescence intensity of LS301(Dose Expansion only) [ Time Frame: Day 1 (at the time of surgery) ]
    • Determined by quantitative near-infrared fluorescence microscopy in continuous scale and will be analyzed in binary scale (presence/absence) with "presence" defined if the fluorescence intensity is at least 20% higher than in the matched normal specimen, indicating detection of tumor cells.
    • Fluorescence in the excised tissue at the margins will be determined by quantitative near-infrared fluorescence microscopy.
    • At least 4 specimens from excised tissue will be analyzed, including suspected tumor and suspected healthy tissue.



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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 Stage I-II breast cancer patients undergoing breast-conserving therapy and SLN biopsy.
  • Negative nodal basin clinical exam.
  • At least 18 years of age.
  • 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.
  • 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): NCT02807597


Contacts
Contact: Julie Margenthaler, M.D. 314-362-7534 margenthaler@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Julie Margenthaler, M.D.    314-362-7534    margenthaler@wustl.edu   
Principal Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Samuel Achilefu, Ph.D.         
Sub-Investigator: Farrokh Dehdashti, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Julie Margenthaler, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02807597     History of Changes
Other Study ID Numbers: 16-x132
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases