Evaluation of a radioactive and fluorescent hybrid tracer for sentinel lymph node biopsy in head and neck malignancies: prospective randomized clinical trial to compare ICG-99mTc-nanocolloid hybrid tracer versus 99mTc-nanocolloid
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There is some controversy about the value of sentinel lymph node excision (SLNE) in patients with head and neck malignancies. The gold standard for detection and targeted extirpation of the SLN is lymphoscintigraphy with 99mTc-nanocolloid. The purpose of this prospective randomized study was to analyse the feasibility and clinical benefit of a hybrid tracer comprising the near-infrared (NIR) fluorescent indocyanine green (ICG) and 99mTc-nanocolloid (ICG-99mTc-nanocolloid) in direct comparison with standard 99mTc-nanocolloid for guiding SLNE in patients with head and neck cutaneous malignancies.
We analysed the data from 40 clinically lymph node-negative patients with melanoma, high-risk cutaneous squamous cell carcinoma, Merkel cell carcinoma or sweat gland carcinoma who underwent SLNE with ICG-99mTc-nanocolloid (cohort A) or with the standard 99mTc-nanocolloid (cohort B).
Overall SLNs were identified preoperatively in all 20 patients (100 %) in cohort A and in 18 of 20 patients (90 %) in cohort B. The SLN basin was detected preoperatively in 18 patients (90 %) in cohort A and also in 18 patients (90 %) in cohort B. SLNs were identified intraoperatively in all 20 patients (100 %) in cohort A and in 19 patients (95 %) in cohort B (p = 0.487). Metastatic SLNs were detected in 9 patients (22.5 %), 3 (15.0 %) in cohort A and 6 (30.0 %) in cohort B (p = 0.228).
The hybrid tracer ICG-99mTc-nanocolloid is an innovative imaging tracer, reliably and readily providing additional information for the detection and excision of SLN in the head and neck region. Therefore, SLNE with combined radioactive and NIR fluorescence guidance is an attractive option for improving the SLN detection rate in patients with cutaneous head and neck malignancies.
KeywordsMalignant melanoma Head and neck cancer Sentinel lymph node Hybrid tracer Indocyanine green
Compliance with ethical standards
Conflicts of interest
Dr. Schadendorf reported receiving consultancy fees, having board membership, and receiving lecture fees from GlaxoSmithKline, Novartis, Amgen, Bristol-Myers Squibb, Roche, Genentech, Boehringer Ingelheim and MSD. The other authors declare that they have no conflicts of interest.
All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional research committee and with the principles of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Statement on the welfare of animals
This article does not describe any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study.
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