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

Overview

This is a pilot study to test and characterize the ability of the SmartGoggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the SmartGoggles 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 Title of Study: “Evaluation of an Integrated Imaging System (Smartgoggles) For In Vivo Detection of Fluorescently Labeled Lesions: A Pilot Study To Visualize Sentinel Lymph Nodes After Peritumoral Injection of Indocyanine Green”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Detailed Description

Primary Objective -Positive fluorescence signal in SLNs imaged by the SmartGoggles system.

Secondary Objectives

- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.

- Comparison of lesions detected by the SmartGoggles vs. lesions detected using SPY Elite 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 SmartGoggles 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 biopsies will be performed if multiple SLNs are identified. The study will enroll 6 patients, and then be suspended for an interim analysis. If it is determined that more data are needed to reliably determine the endpoints, then 4 additional patients will be recruited, for a total of 10 patents.

Interventions

  • Device: SmartGoggle
    • SmartGoggle 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 SmartGoggles 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
    • Previously validated fluorescence detection system. Will be used to look at the same regions as the SmartGoggles 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.

Arms, Groups and Cohorts

  • Experimental: Integrated Imaging Goggles
    • Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by SPY Elite in addition to those detected by gamma probe and blue dyes.

Clinical Trial Outcome Measures

Primary Measures

  • binary response of the number of patients in which the SmartGoggles identifies the same Sentinel Lymph Nodes (SLN) within each patient 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 patients would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 patients, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 patients, enrollment will continue to 10 patients or until a second failed agreement occurs.

Secondary Measures

  • binary response of the number of patients in which the SmartGoggles identifies the same Sentinel Lymph Nodes (SLN) within each patient as those identified by the SPY Elite imaging system.
    • Time Frame: At the end of the procedure, about 50 minutes
    • A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the patient. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve.
  • Number of samples with ICG detected in biopsy tissue
    • Time Frame: At the end of the procedure, about 50 minutes
    • Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
  • Number of samples with lymph node detected in biopsy tissue
    • Time Frame: At the end of the procedure, about 50 minutes
    • Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen Grobmyer, MD, Principal Investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
  • Overall Contact(s)
    • Stephen Grobmyer, MD, 1-866-223-8100, TaussigResearch@ccf.org

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