Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

Study Overview
=================
Brief Summary
-----------------
To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.

Detailed Description
-----------------
This pilot study will enroll three patients who have chosen to proceed with deep inferior epigastric perforator (DIEP) flap breast reconstruction. This type of reconstruction uses skin and fat from the abdomen to reconstruct a new breast shape. The construct is vascularized through perforating arteries and veins that provide a blood supply to this tissue. Current techniques to evaluate vessel selection rely on a handheld Doppler used for confirmation of blood flow and perfusion; however, this modality is limited as it only assesses a specific point within the flap. The S-FLARE imaging system will be used to visualize vascularization in the DIEP flaps, and this study will compare measurements by the S-FLARE imaging system and the standard-of-care ViOptix point probe.

Official Title
-----------------
Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Imaging with S-FLARE imaging system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy. Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist. Exclusion Criteria: BMI > 30.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging with S-FLARE imaging system<br>3 patients to be imaged by S-FLARE imaging system. | Device: Imaging with S-FLARE imaging system<br>* Tissue oxygenation measurements during plastic surgery using the S-FLARE system.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery | Due to patient-to-patient anatomic variation, the vascular perfusion to the skin in DIEP flaps is unpredictable and of great concern to the surgeon planning the flap design. We propose a method of imaging tissue oxygenation within a DIEP flap base on the use of invisible near-infrared light. This pilot study is a comparison study of oxygenation measurements taken by the ViOptix optical probe as the standard of care and the S-FLARE imaging system, with the intention of optimizing the ergonomics and functionality of the S-FLARE imaging system for use during breast reconstructive surgery. | 10 minute imaging procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast reconstruction, breast cancer, near infrared imaging