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

NCT02802553 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CASE4116
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Breast Cancer

Keywords

Smart Goggles; sentinel lymph nodes; indocyanine green; Cardio-Green; Spy Elite; Quest; PDE

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  At the end of the procedure, about 50 minutes

Secondary Outcomes (8)

• 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 samples with lymph node detected in biopsy tissue

  At the end of the procedure, about 50 minutes

• Fluorescence intensity

  Typically no more than 30 minutes

• Number of removed lymph nodes with cancer cells

  At the end of the procedure, about 50 minutes

Study Arms (1)

Integrated Imaging Goggles

EXPERIMENTAL

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.

Device: Smart Goggle; Other: Cardio-Green; Device: SPY Elite Imaging system; Device: Quest near-infrared (NIR) Imaging system; Device: PDE Imaging system; Device: Gamma probe; Other: Blue Dyes

Interventions

Smart Goggle DEVICE

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.

Also known as: Integrated Imaging Goggles

Integrated Imaging Goggles

Cardio-Green OTHER

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.

Also known as: Indocyanine Green

Integrated Imaging Goggles

SPY Elite Imaging system DEVICE

Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity

Integrated Imaging Goggles

Quest near-infrared (NIR) Imaging system DEVICE

Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity

Integrated Imaging Goggles

PDE Imaging system DEVICE

Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity

Integrated Imaging Goggles

Gamma probe DEVICE

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.

Integrated Imaging Goggles

Blue Dyes OTHER

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.

Integrated Imaging Goggles

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephanie A Valente, DO

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: December 28, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)