title: 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-(99m)Tc-nanocolloid hybrid tracer versus (99m)Tc-nanocolloid.
abstract: OBJECTIVE
  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 (99m)Tc-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 (99m)Tc-nanocolloid (ICG-(99m)Tc-nanocolloid) in direct comparison with standard (99m)Tc-nanocolloid for guiding SLNE in patients with head and neck cutaneous malignancies.
  
  
  METHODS
  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-(99m)Tc-nanocolloid (cohort A) or with the standard (99m)Tc-nanocolloid (cohort B).
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  The hybrid tracer ICG-(99m)Tc-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.
authors.affiliation: Department of Dermatology, Venerology and Allergology, University Hospital Essen University of Duisburg-Essen, Hufelandstr. 55, 45122, Essen, Germany.|West German Cancer Center, University Duisburg-Essen, Essen, Germany.|German Cancer Consortium (DKTK), Essen, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Stoffels
authors.affiliation: Department of Dermatology, Venerology and Allergology, University Hospital Essen University of Duisburg-Essen, Hufelandstr. 55, 45122, Essen, Germany.|West German Cancer Center, University Duisburg-Essen, Essen, Germany.|German Cancer Consortium (DKTK), Essen, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Leyh
authors.affiliation: Department of Nuclear Medicine, University Hospital Essen University of Duisburg-Essen, Essen, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Pöppel
authors.affiliation: Department of Dermatology, Venerology and Allergology, University Hospital Essen University of Duisburg-Essen, Hufelandstr. 55, 45122, Essen, Germany.|West German Cancer Center, University Duisburg-Essen, Essen, Germany.|German Cancer Consortium (DKTK), Essen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Schadendorf
authors.affiliation: Department of Dermatology, Venerology and Allergology, University Hospital Essen University of Duisburg-Essen, Hufelandstr. 55, 45122, Essen, Germany. joachim.klode@uk-essen.de.|West German Cancer Center, University Duisburg-Essen, Essen, Germany. joachim.klode@uk-essen.de.|German Cancer Consortium (DKTK), Essen, Germany. joachim.klode@uk-essen.de.
authors.forename: Joachim
authors.initials: J
authors.lastname: Klode
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005456:Fluorescent Dyes / Q000737:chemistry*; D006258:Head and Neck Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D006801:Humans; D007208:Indocyanine Green / Q000737:chemistry*; D061305:Lymphoscintigraphy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011849:Radioactive Tracers; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013668:Technetium Tc 99m Aggregated Albumin / Q000737:chemistry*; D055815:Young Adult
chemical_list: D005456:Fluorescent Dyes; D011849:Radioactive Tracers; D013668:Technetium Tc 99m Aggregated Albumin; C083602:technetium Tc 99m nanocolloid; D007208:Indocyanine Green