The FLARE Intraoperative Near-infrared Fluorescence Imaging System: a First-in-human Clinical Trial in Breast Cancer Sentinel Lymph Node Mapping

Overview

Journal Ann Surg Oncol

Publisher Springer

Specialty Oncology

Date 2009 Jul 8

PMID 19582506

Citations 304

Authors

Susan L Troyan

Vida Kianzad

Summer L Gibbs-Strauss

Sylvain Gioux

Aya Matsui

Rafiou Oketokoun

Long Ngo

Ali Khamene

Fred Azar

John V Frangioni

Affiliations

Soon will be listed here.

Abstract

Background: Invisible NIR fluorescent light can provide high sensitivity, high-resolution, and real-time image-guidance during oncologic surgery, but imaging systems that are presently available do not display this invisible light in the context of surgical anatomy. The FLARE imaging system overcomes this major obstacle.

Methods: Color video was acquired simultaneously, and in real-time, along with two independent channels of NIR fluorescence. Grayscale NIR fluorescence images were converted to visible "pseudo-colors" and overlaid onto the color video image. Yorkshire pigs weighing 35 kg (n = 5) were used for final preclinical validation of the imaging system. A six-patient pilot study was conducted in women undergoing sentinel lymph node (SLN) mapping for breast cancer. Subjects received (99m)Tc-sulfur colloid lymphoscintigraphy. In addition, 12.5 microg of indocyanine green (ICG) diluted in human serum albumin (HSA) was used as an NIR fluorescent lymphatic tracer.

Results: The FLARE system permitted facile positioning in the operating room. NIR light did not change the look of the surgical field. Simultaneous pan-lymphatic and SLN mapping was demonstrated in swine using clinically available NIR fluorophores and the dual NIR capabilities of the system. In the pilot clinical trial, a total of nine SLNs were identified by (99m)Tc- lymphoscintigraphy and nine SLNs were identified by NIR fluorescence, although results differed in two patients. No adverse events were encountered.

Conclusions: We describe the successful clinical translation of a new NIR fluorescence imaging system for image-guided oncologic surgery.

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