NCT02316795

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Cancer of Breast
• Cancer of the Breast
• Melanoma
• Malignant Melanoma

Interventions

Type	Name	Description
PROCEDURE	Sentinel lymph node biopsy
DEVICE	Goggle-based device with light-emitting diodes (LED)
DRUG	Indocynanine Green	This is a infrared fluorescence imaging contrast agent

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2014-12-15
• Last updated: 2019-09-24

Locations

1 site across 1 country: United States