Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | May 1, 2019 |
| End Date: | July 2020 |
| Contact: | Risal Djohan, MD |
| Email: | CancerCenterResearch@ccf.org |
| Phone: | 866-223-8100 |
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.
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.
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.
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.
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
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