Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye

Evaluation of an Integrated Imaging System (SmartGoggles) for in Vivo Visualization of Free Flap Perfusion Using Indocyanine Green Fluorescent Dye

The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures.

The participants will be asked to participate in the study if they are scheduled to have a breast reconstruction procedure using a technique that involves transferring abdominal skin and tissues to the affected side of the chest. This technique is known as a breast reconstruction with a Deep Inferior Epigastric Artery Perforator (DIEP) flap.

In this pilot study, the investigators are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called "Smart Goggles") as a surgical aid to differentiate between tissue with adequate blood flow and tissue without adequate blood flow by comparing measurements of fluorescence in blood vessels with current technology, the SPY-Elite system. In this study, researchers will test how quickly and accurately the fluorescent dye used to identify adequate blood flow is detected by Smart Goggles compared to the SPY Elite system.

Study Overview

• Status: Suspended
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: SmartGoggles

Detailed Description

The objective is to demonstrate the sensitivity of the SmartGoggles for detection of Indocyanine (ICG) fluorescence within fasciocutaneous flap. The investigators will characterize the sensitivity of the SmartGoggles device relative to a previously validated device (the SPY Elite system).

The investigator's primary endpoint will compare the ICG transit time (the time needed for ICG to first appear in flap after intravenous injection) detected by the SmartGoggles and the SPY Elite system.

As a secondary endpoint, the investigators will compare the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests (ROI). Finally, the study team will compare perfusion margin characteristics (the area between regions of well-perfused and hypoperfused tissue) as assessed by the Goggles and the SPY Elite system.

Study Design This is an unpowered pilot study to determine the sensitivity of the new SmartGoggles device for detection of ICG fluorescence in free flaps in a clinical setting. The investigators have chosen to examine ICG as the contrast agent because this agent is FDA-approved and is regularly used for evaluation of tissue perfusion. The team has chosen to use DIEP free flaps as the clinical target because these flaps are relatively large and will provide adequate surface area for measurement of fluorescent margins and comparison of fluorescence between the Goggles and SPY Elite systems.

This study will enroll 25 patients. After signing consent form all patients will undergo standard of care preoperative and postoperative evaluations. Investigators will perform one ICG angiography per patient: intraoperatively after designing and harvesting the flap. All measurements will be taken by SmartGoggles and SPY Elite systems.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing unilateral DIEP flap breast reconstruction
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Pregnant women
• Patients with severe hepatic insufficiency
• Patients with a history of allergic reactions or know hypersensitivity to ICG and iodide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SmartGoggles; The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. Investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nanomolar (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 optical density (OD) 6 level cut-off. The SmartGoggles is a non-invasive imaging system that does not require contact with patients.

Device: SmartGoggles; the system is wearable and simulates natural binocular human vision, which minimizes the training curve for new users. The wide-field stereoscopic imaging allows clinicians to rapidly determine the extent of lesions and the hand-held microscopy probe assist clinician to visualize the lesions with high resolution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICG transit time detected by the SmartGoggles and the SPY Elite system.	The time needed for ICG to first appear in flap after intravenous injection	At the end of surgery - 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests	compared between SmartGoggles and the SPY Elite System using a one-sided non-inferiority analysis based on a paired t-test.	At the end of surgery - 1 day
Difference in square area of perfusion as detected by ICG angiography under the SmartGoggles and SPY Elite systems	This perfusion margin characteristic provides a difference in detection by the two imaging systems	At the end of surgery - 1 day

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Risal Djohan, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Indocyanine green; SmartGoggles
• Other Study ID Numbers: CASE2118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No