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Completed

NCT Number: NCT02316795

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer of Breast Cancer of the Breast Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

Other names: SLN biopsy

Goggle-based device with light-emitting diodes (LED)

Device

Indocynanine Green

Drug

This is a infrared fluorescence imaging contrast agent

Other names: ICG

Primary outcomes

  1. 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?"

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2014
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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