Clinical trial NCT02802553: Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Invasive Breast Cancer
Keywords: Smart Goggles
sentinel lymph nodes
indocyanine green
Cardio-Green
Spy Elite
Quest
PDE
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
timeFrame: At the end of the procedure, about 50 minutes
Secondary outcomes:
measure: Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems.
timeFrame: At the end of the procedure, about 50 minutes
measure: Number of samples with ICG detected in biopsy tissue
timeFrame: At the end of the procedure, about 50 minutes
measure: Number of samples with lymph node detected in biopsy tissue
timeFrame: At the end of the procedure, about 50 minutes
measure: Fluorescence intensity
timeFrame: Typically no more than 30 minutes
measure: Number of removed lymph nodes with cancer cells
timeFrame: At the end of the procedure, about 50 minutes
measure: Sensitivity as measured via the ICG accumulation curve
timeFrame: At the end of the procedure, about 50 minutes
measure: Specificity as measured via the ICG accumulation curve
timeFrame: At the end of the procedure, about 50 minutes
measure: Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras
timeFrame: At the end of the procedure, about 50 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Stephanie A Valente, DO
role: PRINCIPAL_INVESTIGATOR
References: