NCT02423148

Pilot Study of Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer

A Pilot Study of a Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer in Combination With Indo-Cyanine Green

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a new imaging method that will show lymph nodes in the lung during lung cancer surgery. The name of the study intervention involved in this study is: \-- The combination of the FluoSCOPE device and Indocyanine Green

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved Indocyanine Green for your specific disease, but it has been approved for other uses. In this research study, the investigators are interested in learning how a new investigational device, the FluoSCOPE, performs in the operating room. This study will also allow the investigators to optimize the settings of the imaging system. The investigators hope that this device, along with the local injection of Indocyanine Green around the tumor, will help find the sentinel lymph nodes in real-time during the surgery to remove lung cancer. Although this is the first time the FluoSCOPE is being used in humans, the technology of near-infrared fluorescence imaging has been used for the detection of sentinel lymph nodes of patients with breast cancer, skin cancer and lung cancer.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Indocyanine green (ICG)
DEVICE	FluoSCOPE

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-11-03
• Completion: 2016-11-03
• First posted: 2015-04-22
• Last updated: 2018-05-16