Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Melanoma

Breast Diseases

Skin Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

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.

Sentinel lymph node biopsy

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

This is a infrared fluorescence imaging contrast agent

Indocynanine Green

Ryan C Fields, M.D.

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.

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

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

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?"

Washington University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma	NCT02316795	Breast Cancer Cancer of Breas... Cancer of the B... Melanoma Malignant Melan...	Sentinel lymph ... Goggle-based de... Indocynanine Gr...	18 Years -	Washington University School of Medicine
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma	NCT02316795	Breast Cancer Cancer of Breas... Cancer of the B... Melanoma Malignant Melan...	Sentinel lymph ... Goggle-based de... Indocynanine Gr...	18 Years -	Washington University School of Medicine

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