Clinical trial NCT03625765: Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye
Official title: Evaluation of an Integrated Imaging System (SmartGoggles) for in Vivo Visualization of Free Flap Perfusion Using Indocyanine Green Fluorescent Dye
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Reconstruction
Keywords: Indocyanine green
SmartGoggles
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ICG transit time detected by the SmartGoggles and the SPY Elite system.
timeFrame: At the end of surgery - 1 day
Secondary outcomes:
measure: Difference in the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests
timeFrame: At the end of surgery - 1 day
measure: Difference in square area of perfusion as detected by ICG angiography under the SmartGoggles and SPY Elite systems
timeFrame: At the end of surgery - 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Risal Djohan, MD
role: PRINCIPAL_INVESTIGATOR
References: