Objective Flap Assessment During Reconstructive Surgery

Early Phase 1

Completed

• Conditions: Cancer
• Interventions: Device: FLARE imaging system

• Registration Number: NCT00952107
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

Detailed Description

To perform a pilot study of the FLARE™ 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging system operation	FLARE imaging system	-

Primary Outcome Measures

Name	Time	Method
System operation	2 minutes

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States