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Cited by 684

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The FLARE™ Intraoperative Near-Infrared Fluorescence Imaging System: A First-in-Human Clinical Trial in Breast Cancer Sentinel Lymph Node Mapping

Open access
Troyan, Susan L., Kianzad, Vida, Gibbs-Strauss, Summer L., Gioux, Sylvain, Matsui, Aya, Oketokoun, Rafiou, Ngo, Long, Khamene, Ali, Azar, Fred, Frangioni, John V.·2009·Annals of Surgical Oncology

Abstract

BackgroundInvisible 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.MethodsColor 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 99mTc-sulfur colloid lymphoscintigraphy. In addition, 12.5 μg of indocyanine green (ICG) diluted in human serum albumin (HSA) was used as an NIR fluorescent lymphatic tracer.ResultsThe 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 99mTc- lymphoscintigraphy and nine SLNs were identified by NIR fluorescence, although results differed in two patients. No adverse events were encountered.ConclusionsWe describe the successful clinical translation of a new NIR fluorescence imaging system for image-guided oncologic surgery.

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Metadata

Authors
Troyan, S. L., Kianzad, V., Gibbs-Strauss, S. L., Gioux, S., Matsui, A., Oketokoun, R., Ngo, L., Khamene, A., Azar, F., & Frangioni, J. V.
Venue
Annals of Surgical Oncology
Published
2009-07-07
Volume
16
Issue
10
Pages
2943-2952
ISSN
  • 1068-9265 (ISSN-L)
  • 1534-4681
OpenAlex
W2168544783
Cited by
684
References
1
FWCI
32.88
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: The FLARE™ Intraoperative Near-Infrared Fluorescence Imaging System: A First-in-Human Clinical Trial in Breast Cancer Sentinel Lymph Node Mapping. https://app.cochat.ai/papers/10.1245/s10434-009-0594-2
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Troyan, S. L., Kianzad, V., Gibbs-Strauss, S. L., Gioux, S., Matsui, A., Oketokoun, R., Ngo, L., Khamene, A., Azar, F., & Frangioni, J. V. (2009). The FLARE™ Intraoperative Near-Infrared Fluorescence Imaging System: A First-in-Human Clinical Trial in Breast Cancer Sentinel Lymph Node Mapping. Annals of Surgical Oncology. https://doi.org/10.1245/s10434-009-0594-2

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Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.