The FLARE™ intraoperative near-infrared fluorescence imaging system: A first-in-human clinical trial in breast cancer sentinel lymph node mapping

Susan L. Troyan, Vida Kianzad, Summer Gibbs, Sylvain Gioux, Aya Matsui, Rafiou Oketokoun, Long Ngo, Ali Khamene, Fred Azar, John V. Frangioni

Research output: Contribution to journalArticle

459 Citations (Scopus)

Abstract

Background. Invisible NIR fluorescent light can provide high sensitivity, high-resolution, and real-time imageguidance 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 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. 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 99mTc-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 imageguided oncologic surgery.

Original languageEnglish (US)
Pages (from-to)2943-2952
Number of pages10
JournalAnnals of Surgical Oncology
Volume16
Issue number10
DOIs
StatePublished - Oct 2009
Externally publishedYes

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Optical Imaging
Lymphoscintigraphy
Color
Fluorescence
Clinical Trials
Breast Neoplasms
Light
Swine
Indocyanine Green
Colloids
Operating Rooms
Sulfur
Serum Albumin
Anatomy
Sentinel Lymph Node

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

The FLARE™ intraoperative near-infrared fluorescence imaging system : A first-in-human clinical trial in breast cancer sentinel lymph node mapping. / Troyan, Susan L.; Kianzad, Vida; Gibbs, Summer; Gioux, Sylvain; Matsui, Aya; Oketokoun, Rafiou; Ngo, Long; Khamene, Ali; Azar, Fred; Frangioni, John V.

In: Annals of Surgical Oncology, Vol. 16, No. 10, 10.2009, p. 2943-2952.

Research output: Contribution to journalArticle

Troyan, Susan L. ; Kianzad, Vida ; Gibbs, Summer ; Gioux, Sylvain ; Matsui, Aya ; Oketokoun, Rafiou ; Ngo, Long ; Khamene, Ali ; Azar, Fred ; Frangioni, John V. / The FLARE™ intraoperative near-infrared fluorescence imaging system : A first-in-human clinical trial in breast cancer sentinel lymph node mapping. In: Annals of Surgical Oncology. 2009 ; Vol. 16, No. 10. pp. 2943-2952.
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AU - Troyan, Susan L.

AU - Kianzad, Vida

AU - Gibbs, Summer

AU - Gioux, Sylvain

AU - Matsui, Aya

AU - Oketokoun, Rafiou

AU - Ngo, Long

AU - Khamene, Ali

AU - Azar, Fred

AU - Frangioni, John V.

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N2 - Background. Invisible NIR fluorescent light can provide high sensitivity, high-resolution, and real-time imageguidance 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 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. 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 99mTc-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 imageguided oncologic surgery.

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