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Objective Flap Assessment During Reconstructive Surgery


Phase 0
21 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Objective Flap Assessment During Reconstructive Surgery


To perform a pilot study of the FLAREā„¢ NIR fluorescence imaging system in conjunction with
indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior
epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous
elements in flaps is unpredictable and of great concern to the surgeon planning the design
of the flap. We propose a method of imaging the flap based on the use of invisible
near-infrared fluorescent light that has significant advantages for both patient and
surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine
optimal dose, light excitation fluence rate, and camera exposure time.


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:

- Patients with a known or suspected iodide or seafood allergy.

- Patients with known renal, cardiac, hepatic, or pulmonary disease.

- BMI > 30

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

System operation

Outcome Time Frame:

2 minutes

Safety Issue:

No

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:

2009P-000095/1; BIDMC

NCT ID:

NCT00952107

Start Date:

June 2009

Completion Date:

February 2012

Related Keywords:

  • Cancer
  • breast cancer
  • breast reconstructive surgery
  • flap assessment

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215