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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Integrated Imaging Goggles
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.
Intervention: Smart Goggle (Device)
Integrated Imaging Goggles
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.
Intervention: Cardio-Green (Other)
Integrated Imaging Goggles
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.
Intervention: SPY Elite Imaging system (Device)
Integrated Imaging Goggles
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.
Intervention: Quest near-infrared (NIR) Imaging system (Device)
Integrated Imaging Goggles
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.
Intervention: PDE Imaging system (Device)
Integrated Imaging Goggles
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.
Intervention: Gamma probe (Device)
Integrated Imaging Goggles
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.
Intervention: Blue Dyes (Other)
Outcomes
Primary Outcomes
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.
Time Frame: At the end of the procedure, about 50 minutes
Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
Secondary Outcomes
- Fluorescence intensity(Typically no more than 30 minutes)
- Sensitivity as measured via the ICG accumulation curve(At the end of the procedure, about 50 minutes)
- Specificity as measured via the ICG accumulation curve(At the end of the procedure, about 50 minutes)
- 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.(At the end of the procedure, about 50 minutes)
- Number of samples with ICG detected in biopsy tissue(At the end of the procedure, about 50 minutes)
- Number of removed lymph nodes with cancer cells(At the end of the procedure, about 50 minutes)
- Number of samples with lymph node detected in biopsy tissue(At the end of the procedure, about 50 minutes)
- Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras(At the end of the procedure, about 50 minutes)