Sentinel Node Localization

Yolonda L. Colson, MD, PhD

Professor of Surgery, Harvard Medical School

Vice Chair for Surgical Innovation Executive Director, Center for Surgical

Innovation

Associate Administrative Chief, Division of Thoracic Surgery at BWH

Dana Farber Cancer Institute / Brigham & Women’s Cancer Center

NIR Image-guided Lymphatic Mapping in Lung Cancer

Disclosures• I have no equity, ownership, stock, options or

any interest in any company

• I do not consult for any company

•We gratefully acknowledge Novadaq for the generous loan of the Pinpoint system. There has been no data preview or monetary sponsorship for this collaboration• I have presented our NIH-funded data on NIR-

imaging at a Novadaq-sponsored conference but without honorarium

•Use of ICG for NIR-imaging of SLN is NOT FDA-approved

Why Consider SLN Mapping in Lung Cancer?

•Almost 30% of Clinical stage I NSCLC patients upstaged at surgery due to occult nodal disease

•Sites of Missed Nodal disease ▫Residual lymph nodes: only 50% of patients

undergo a complete lymphadenectomy.

▫Micrometastasis: 16-18% of “node negative” patients harbor positive LN disease with further histologic scrutiny.

▫Skip Metastases: ~20% of “first tumor-draining lymph nodes” (i.e. SLN) at N2 station.

Group Year Technique Success

Little et al 1999 Single Center Blue Dye 47%

Liptay et al 2000 Single Center Radioisotope 81%

Liptay et al 2009 Multi-Center Radioisotope 51%

Nomori et al 2007 Single Center Pre-op Radioisotope 81%

Schmidt et al 2002 Single Center Intra-operative Blue Dye/ Radioisotope

81%

Tiffet et al 2005 Single Center Intra-operative Blue Dye/ Radioisotope

54%

No Reliable SLN Technology for Lung Cancer

SLN Mapping in Lung Cancer

“Conventional Methods” Mixed Success▫Low Signal▫Anatomic Limitations

Lipid

NIR Window

Courtesy of J. Frangioni, BIDMC

Advantages of NIR Fluorescent Imaging

High signal-to-background ratio▫Low NIR Autoflourescence▫High Fluorophore Signal in

NIRInvisible to the human eye▫No alteration of Surgical

FieldIncreased Safety▫No radioactivity or laser

risk

Real-time visualization of target

during surgical dissection

Excitation of the Indocyanine Green (ICG) captured by a near-infrared camera

• Indocyanine Green (ICG) emission in NIR spectra: 750-950nm

• ICG signal detection via NIR videoscopic camera

• Visualization of merged and single channel images in real-time

Light Source

Surgical Field

NIRCame

ra

Color VideoCame

ra

Video of Real-time Merged Images

Courtesy of J. Frangioni, BIDMC.

How Does it Work?

Lesion Characteristics Dictate NIR Approach

How I Do It

0%

20%

40%

60%

80%

100%

Pathology of NIR+ SLN Predicts Overall Nodal

Status

Pathology of NIR+ SLN

% p

ts w

ith

an

y n

od

al

dis

ease

Pos. Neg.

Summary•32 SLN in 20 patients ▫ ICG Dose Dependent

▫Dose optimized at 2.5mg

▫N1 Stations – 21 LN▫N2 Stations – 11 LN

•No Adverse events •SLN status predictive

of nodal metastases in all patients

N=7 n=13

0%

Conclusion

•NIR guided lymphatic mapping appears to be a safe & feasible approach to identify SLN

•Learning curve is initially high

•May improve intraoperative staging with identification of micrometastatic disease in lung cancer patients

•Still an experimental approach and has not been evaluated for long-term safety or for SLN accuracy in a sufficient number of patients to be standard of care

•Large prospective clinical trial is needed

Funding & SupportNational Cancer Institute – R01-CA131044

American College of Surgeons Clowes AwardEdward M. Kennedy Award for Healthcare

InnovationCenter for Integration of Medicine & Innovative

Technology (CIMIT)

TalentHisashi Tsukada (BWH), John Frangioni

(BIDMC) Krista Hachey, Denis Gilmore, Onkar Khullar

Katie Armstrong, David Owens

Acknowledgments