Near Infrared Fluorescent Lymph Node Mapping with Indocyanine Green in Breast Cancer Patients: A Prospective Trial - 17/03/19

Doi : 10.1016/j.jamcollsurg.2018.12.001

Stephanie A. Valente, DO, FACS ^a, Zahraa Al-Hilli, MD, FACS ^a, Diane M. Radford, MD, FACS ^a, Courtney Yanda, MS ^a, Chao Tu, MS ^b, Stephen R. Grobmyer, MD, FACS ^a,^⁎
^a Division of Breast Surgery, Department of General Surgery, Cleveland Clinic, Cleveland, OH
^b Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH

^∗Correspondence address: Stephen R Grobmyer, MD, FACS, Division of Breast Surgery, Department of General Surgery, Cleveland Clinic, 9500 Euclid Ave A80, Cleveland, OH 44195.Division of Breast SurgeryDepartment of General SurgeryCleveland Clinic9500 Euclid Ave A80ClevelandOH44195

Abstract

Background

Near infrared (NIR) fluorescence imaging is an emerging modality that can enable real-time image-guided procedures. Indocyanine green (ICG) is an FDA-approved, inexpensive, and widely available NIR dye. We hypothesized that axillary lymphatic mapping with ICG is equivalent to lymphatic mapping with technetium 99m (^99mTc) in breast cancer patients.

Study Design

Breast cancer patients (cT1-2, N0) were prospectively enrolled. Patients underwent lymphatic mapping with ^99mTc preoperatively and ICG mapping intraoperatively (0.8 mL). Sentinel lymph node (SLN) biopsy was guided by NIR camera and gamma probe. Rate of failed mapping, number of SLNs identified, and rate of identifying pathologically positive SLNs were compared between the 2 techniques (p < 0.05 was considered statistically significant).

Results

Ninety-two female patients were enrolled (median age 59 years). Mean transit time from ICG injection in the breast to localization in the axilla was 5 minutes (range 2 to 29 minutes). No adverse reactions to ICG were noted. Mean number of SLNs identified with ICG and ^99mTc was 2.4 (SD 1.42) and 2.2 (SD 1.23), respectively (p = 0.34). Pathologically positive SLNs were identified in 18 (19.8%) patients. A total of 24 pathologically positive SLNs in 18 patients were identified by ICG in 24 of 24 (100%) patients and by ^99mTc in 23 of 24 (96%) patients (p = 0.99).

Conclusions

Indocyanine green with NIR fluorescence imaging can be safely and efficiently used for real-time intraoperative lymphatic mapping in breast cancer patients. Indocyanine green performs similarly to ^99mTc with regard to the number of SLNs identified, rate of failed mapping, and identification of pathologically positive SLNs.

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Abbreviations and Acronyms : ICG, NIR, SLN, ^99mTc

Plan

	Disclosure Information: Near infrared camera and indocyanine green study drug were provided by Mitaka USA.
	Disclosures outside the scope of this work: Drs Al-Hilli, Grobmyer, and Valente receive researchsupportfromLumicell. Dr Grobmyer received researchsupportfromGrail, is a board member of Seno Medical, and received travel stipend from Zeiss Meditech. Dr Valente received travel stipend from Zeiss Meditech.