TY - JOUR
T1 - Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer
AU - Mieog, J. Sven D.
AU - Troyan, Susan L.
AU - Hutteman, Merlijn
AU - Donohoe, Kevin J.
AU - Van Der Vorst, Joost R.
AU - Stockdale, Alan
AU - Liefers, Gerrit Jan
AU - Choi, Hak Soo
AU - Gibbs-Strauss, Summer L.
AU - Putter, Hein
AU - Gioux, Sylvain
AU - Kuppen, Peter J.K.
AU - Ashitate, Yoshitomo
AU - Löwik, Clemens W.G.M.
AU - Smit, Vincent T.H.B.M.
AU - Oketokoun, Rafiou
AU - Ngo, Long H.
AU - Van De Velde, Cornelis J.H.
AU - Frangioni, John V.
AU - Vahrmeijer, Alexander L.
N1 - Funding Information:
ACKNOWLEDGMENT The BIDMC study team thanks Barbara L. Clough and Mireille Rosenberg for clinical trial preparation, Keith V. Belken from the BIDMC Investigational Pharmacy, Judith Hirshfield-Bartek for assistance with patient medical histories, Sunil Gupta for technical assistance with the imaging system, Lorissa A. Moffitt and Lindsey Gendall for editing, and Eugenia Trabucchi for administrative support. The Leiden study team thanks Gemma Ranke, Elly Krol-Warmerdam, Annemarie Voet-van den Brink, Gerlinda van Gent-de Bruijn (Breast Cancer Unit), and Linda van der Hulst (Central Pharmacy). Part of the study protocol was written during the 10th ECCO-AACR-ASCO Workshop on Methods in Clinical Cancer Research (Flims, Switzerland). We thank the following individuals and companies for their contributions to this project: Gordon Row (Yankee Modern Engineering), Kelly Stockwell and Paul Millman (Chroma Technology), David Comeau and Robert Waitt (Albright Technologies), Bob Zinter, Gary Avery, Phil Dillon, Will Barker, Craig Shaffer, and Ed Schultz (Qioptiq), Jeffrey Thumm (Duke River Engineering), Colin Johnson (LAE Technologies), Robert Eastlund (Graftek Imaging), John Fortini (Lauzon Manufacturing), Steve Hu-chro (Solid State Cooling), Clay Sakewitz, Johnny Fraga, and Will Richards (Design and Assembly Concepts), Ken Thomas and Fer-nando Irizarry (Sure Design), Paul Bistline and Phil Bonnette (Medical Technique, Inc.), Amy King (Civco), and Jim Cuthbertson (Nashua Circuits). This study was supported in part by the following grants from the National Institutes of Health (National Cancer Institute) to JVF: NIH Bioengineering Research Partnership grant No. R01-CA-115296 (JVF), Quick Trials for Imaging grant No. R21-CA-130297 (JVF), Nuts Ohra Fund (ALV), the Maurits and Anna de Kock Foundation (ALV), and the American Women’s Club of The Hague. JSDM is a MD-medical research trainee funded by The Netherlands Organisation for Health Research and Development (grant No. 92003526).
PY - 2011/9
Y1 - 2011/9
N2 - Background: Near-infrared (NIR) fluorescent sentinel lymph node (SLN) mapping in breast cancer requires optimized imaging systems and lymphatic tracers. Materials and Methods: A small, portable version of the FLARE imaging system, termed Mini-FLARE, was developed for capturing color video and two semi-independent channels of NIR fluorescence (700 and 800 nm) in real time. Initial optimization of lymphatic tracer dose was performed using 35-kg Yorkshire pigs and a 6-patient pilot clinical trial. More refined optimization was performed in 24 consecutive breast cancer patients. All patients received the standard of care using 99mTechnetium-nanocolloid and patent blue. In addition, 1.6 ml of indocyanine green adsorbed to human serum albumin (ICG:HSA) was injected directly after patent blue at the same location. Patients were allocated to 1 of 8 escalating ICG:HSA concentration groups from 50 to 1000 μM. Results: The Mini-FLARE system was positioned easily in the operating room and could be used up to 13 in. from the patient. Mini-FLARE enabled visualization of lymphatic channels and SLNs in all patients. A total of 35 SLNs (mean = 1.45, range 1-3) were detected: 35 radioactive (100%), 30 blue (86%), and 35 NIR fluorescent (100%). Contrast agent quenching at the injection site and dilution within lymphatic channels were major contributors to signal strength of the SLN. Optimal injection dose of ICG:HSA ranged between 400 and 800 μM. No adverse reactions were observed. Conclusions: We describe the clinical translation of a new NIR fluorescence imaging system and define the optimal ICG:HSA dose range for SLN mapping in breast cancer.
AB - Background: Near-infrared (NIR) fluorescent sentinel lymph node (SLN) mapping in breast cancer requires optimized imaging systems and lymphatic tracers. Materials and Methods: A small, portable version of the FLARE imaging system, termed Mini-FLARE, was developed for capturing color video and two semi-independent channels of NIR fluorescence (700 and 800 nm) in real time. Initial optimization of lymphatic tracer dose was performed using 35-kg Yorkshire pigs and a 6-patient pilot clinical trial. More refined optimization was performed in 24 consecutive breast cancer patients. All patients received the standard of care using 99mTechnetium-nanocolloid and patent blue. In addition, 1.6 ml of indocyanine green adsorbed to human serum albumin (ICG:HSA) was injected directly after patent blue at the same location. Patients were allocated to 1 of 8 escalating ICG:HSA concentration groups from 50 to 1000 μM. Results: The Mini-FLARE system was positioned easily in the operating room and could be used up to 13 in. from the patient. Mini-FLARE enabled visualization of lymphatic channels and SLNs in all patients. A total of 35 SLNs (mean = 1.45, range 1-3) were detected: 35 radioactive (100%), 30 blue (86%), and 35 NIR fluorescent (100%). Contrast agent quenching at the injection site and dilution within lymphatic channels were major contributors to signal strength of the SLN. Optimal injection dose of ICG:HSA ranged between 400 and 800 μM. No adverse reactions were observed. Conclusions: We describe the clinical translation of a new NIR fluorescence imaging system and define the optimal ICG:HSA dose range for SLN mapping in breast cancer.
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U2 - 10.1245/s10434-011-1566-x
DO - 10.1245/s10434-011-1566-x
M3 - Article
C2 - 21360250
AN - SCOPUS:80052722437
SN - 1068-9265
VL - 18
SP - 2483
EP - 2491
JO - Annals of surgical oncology
JF - Annals of surgical oncology
IS - 9
ER -