NCT02802553

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
DEVICE	Smart Goggle	Smart Goggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The Smart Goggles is a non-invasive imaging system that does not require contact with patients.
OTHER	Cardio-Green	Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.
DEVICE	SPY Elite Imaging system	Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
DEVICE	Quest near-infrared (NIR) Imaging system	Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
DEVICE	PDE Imaging system	Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
DEVICE	Gamma probe	Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.
OTHER	Blue Dyes	Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.

Timeline

• Start date: 2017-12-28
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2016-06-16
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study