Background On average, 21% of women in the USA treated with Breast Conserving Surgery (BCS) undergo a second operation because of close positive margins. Tumor identification with fluorescence imaging could improve positive margin rates through demarcating location, size, and invasiveness of tumors. We investigated the technique’s diagnostic accuracy in detecting tumors during BCS using intravenous indocyanine green (ICG) and a custom-built fluorescence camera system. Methods In this single-center prospective clinical study, 40 recruited BCS patients were sub-categorized into two cohorts. In the first ‘enhanced permeability and retention’ (EPR) cohort, 0.25 mg/kg ICG was injected ~ 25 min prior to tumor excision, and in the second ‘angiography’ cohort, ~ 5 min prior to tumor excision. Subsequently, an in-house imaging system was used to image the tumor in situ prior to resection, ex vivo following resection, the resection bed, and during grossing in the histopathology laboratory to compare the technique’s diagnostic accuracy between the cohorts. Results The two cohorts were matched in patient and tumor characteristics. The majority of patients had invasive ductal carcinoma with concomitant ductal carcinoma in situ. Tumor-to-background ratio (TBR) in the angiography cohort was superior to the EPR cohort (TBR = 3.18 ± 1.74 vs 2.10 ± 0.92 respectively, p = 0.023). Tumor detection reached sensitivity and specificity scores of 0.82 and 0.93 for the angiography cohort and 0.66 and 0.90 for the EPR cohort, respectively (p = 0.1051 and p = 0.9099). Discussion ICG administration timing during the angiography phase compared with the EPR phase improved TBR and diagnostic accuracy. Future work will focus on image pattern analysis and adaptation of the camera system to targeting fluorophores specific to breast cancer.

Introduction Conventional methods for axillary sentinel lymph node biopsy (SLNB) are fraught with complications such as allergic reactions, skin tattooing, radiation, and limitations on infrastructure. A novel technique has been developed for lymphatic mapping utilizing fluorescence imaging. This meta-analysis aims to compare the gold standard blue dye and radioisotope (BD-RI) technique with fluorescence-guided SLNB using indocyanine green (ICG). Methods This study was registered with PROSPERO (CRD42019129224). The MEDLINE, EMBASE, Scopus, and Web of Science databases were searched using the Medical Subject Heading (MESH) terms ‘Surgery’ AND ‘Lymph node’ AND ‘Near infrared fluorescence’ AND ‘Indocyanine green’. Studies containing raw data on the sentinel node identification rate in breast cancer surgery were included. A heterogeneity test (using Cochran’s Q) determined the use of fixed- or random-effects models for pooled odds ratios (OR). Results Overall, 1748 studies were screened, of which 10 met the inclusion criteria for meta-analysis. ICG was equivalent to radioisotope (RI) at sentinel node identification (OR 2.58, 95% confidence interval [CI] 0.35–19.08, p < 0.05) but superior to blue dye (BD) (OR 9.07, 95% CI 6.73–12.23, p < 0.05). Furthermore, ICG was superior to the gold standard BD-RI technique (OR 4.22, 95% CI 2.17–8.20, p < 0.001). Conclusion Fluorescence imaging for axillary sentinel node identification with ICG is equivalent to the single technique using RI, and superior to the dual technique (RI-BD) and single technique with BD. Hospitals using RI and/or BD could consider changing their practice to ICG given the comparable efficacy and improved safety profile, as well as the lesser burden on hospital infrastructure.