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Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions

Invasive Breast Cancer Clinical Trial

Official title:
Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green

Clinical Trial Summary

This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.

Clinical Trial Description

Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system. Secondary Objectives - Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy. - Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes. Exploratory Objectives -Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting ~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02802553
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Stephanie A Valente, DO
Phone 1-866-223-8100
Email TaussigResearch@ccf.org
Status Recruiting
Phase N/A
Start date December 28, 2017
Completion date December 2024
View Details
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