Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

September 23, 2019 updated by: Washington University School of Medicine

Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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.

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 with clinically node-negative breast cancer or melanoma being staged with 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, including known iodide or seafood allergy.
  • Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant.
  • 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 ICG dye.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLN biopsy with ICG injection

During the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure.

After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed.
Procedure: Sentinel lymph node biopsy
Other Names:
  • SLN biopsy
Device: Goggle-based device with light-emitting diodes (LED)
Drug: Indocynanine Green
This is a infrared fluorescence imaging contrast agent
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN
Time Frame: At the time of the biopsy procedure (approximately 1.5 hours)

After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols.

Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid.

Fluorescence imaging results will be classified in relation to the "true" status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN.

The main data point collected is "Do ICG-identified node (s) have extra-corporeal gamma activity?"
At the time of the biopsy procedure (approximately 1.5 hours)

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Publications and helpful links

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

General Publications

Helpful Links

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 Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201302102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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