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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03625765
• Other study ID #: CASE2118
• Status: Suspended
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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