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


Phase 1
21 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery

Outcome Description:

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.

Outcome Time Frame:

10 minute imaging procedure

Safety Issue:

Yes

Principal Investigator

John V. Frangioni, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

2009-P000384 BIDMC

NCT ID:

NCT01116297

Start Date:

January 2010

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • breast reconstruction
  • breast cancer
  • near infrared imaging
  • Breast Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215