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

Completed · Early Phase 1

Conditions studied: Breast Cancer, Cancer of Breast, Cancer of the Breast, Melanoma, Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT02316795

Run by

Washington University School of Medicine

People needed

20

Starts

2014-02-01

Expected to finish

2015-12-01

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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