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

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.

Conditions

• Invasive Breast Cancer

Interventions

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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Stephanie A Valente, DO · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-28

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• United States

Study Locations