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

Case Comprehensive Cancer Center (Case CCC)

Status

Active, not recruiting

Conditions

Invasive Breast Cancer

Treatments

Device: Gamma probe

Device: PDE Imaging system

Device: Smart Goggle

Other: Cardio-Green

Device: Quest near-infrared (NIR) Imaging system

Device: SPY Elite Imaging system

Other: Blue Dyes

Study type

Interventional

Funder types

Other

Identifiers

NCT02802553

CASE4116

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with at least 1 lesion of tumor of the breast
Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Subjects who have been treated with radiation therapy on the chest.
Has had previous sentinel lymph node biopsy
Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Integrated Imaging Goggles

Experimental group

Description:

Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes.