title: Intraoperative Fluorescence Imaging for Sentinel Lymph Node Detection: Prospective Clinical Trial to Compare the Usefulness of Indocyanine Green vs Technetium Tc 99m for Identification of Sentinel Lymph Nodes.
abstract: OBJECTIVE
  The metastatic status of regional lymph nodes is the most relevant prognostic factor in breast cancer, melanoma, and other solid organ tumors with a lymphatic spread. The current gold standard for detection and targeted excision of the sentinel lymph node is preoperative lymphoscintigraphy with technetium Tc 99m. Because of the worldwide shortage of technetium Tc 99m, physicians are looking for nonradioactive dyes for sentinel lymph node labeling. Based on several retrospective studies, the fluorescent dye indocyanine green is considered a possible alternative to technetium Tc 99m.
  
  
  OBJECTIVE
  To analyze the feasibility and clinical benefit of intraoperative near infrared fluorescence sentinel lymph node excision (SLNE) compared with standard technetium Tc 99m-guided SLNE using malignant melanoma in which SLNE is firmly established.
  
  
  METHODS
  Analysis of a prospective clinical trial at the Skin Cancer Center, University Hospital Essen. Eighty patients with malignant melanoma on the trunk or extremities (upper and lower) who were scheduled to undergo SLNE were included in this study from January 1, 2013, to June 27, 2014.
  
  
  METHODS
  Concordance of preoperative and intraoperative sentinel lymph node detection rates.
  
  
  RESULTS
  During the study period, 80 patients were operated on with an additional intraoperative application of a near infrared fluorescent dye. In these 80 surgical procedures, 147 SLNs were excised. Detection of a technetium Tc 99m-marked SLN before surgery was possible in all cases. Intraoperative visualization of the SLN by indocyanine green before skin incision was successful in only 17 of 80 patients (21%). The number of SLNs identified using the near infrared fluorescence technique in the operative site after skin incision and initial tissue preparation was 141 of 147 (96%).
  
  
  CONCLUSIONS
  Among patients in whom the lymph node basin cannot be predicted correctly (eg, in cutaneous melanoma on the trunk), the use of indocyanine green for SLN detection is severely limited compared with SLNE using standard technique guided by technetium Tc 99m. Therefore, SLNE with the use of radiocolloid, followed if possible by single-photon emission computed tomography, remains the gold standard.
  
  
  BACKGROUND
  German Clinical Trials Register identifier DRKS00004619.
authors.affiliation: Department of Dermatology, Venereology and Allergology, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Stoffels
authors.affiliation: Department of Dermatology, Venereology and Allergology, University of Duisburg-Essen, Essen, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Dissemond
authors.affiliation: Department of Nuclear Medicine, University of Duisburg-Essen, Essen, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Pöppel
authors.affiliation: Department of Dermatology, Venereology and Allergology, University of Duisburg-Essen, Essen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Schadendorf
authors.affiliation: Department of Dermatology, Venereology and Allergology, University of Duisburg-Essen, Essen, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Klode
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004396:Coloring Agents; D005260:Female; D005453:Fluorescence; D005500:Follow-Up Studies; D006801:Humans; D007208:Indocyanine Green; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D061305:Lymphoscintigraphy; D008297:Male; D008545:Melanoma / Q000175:diagnosis* / Q000556:secondary / Q000601:surgery; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods*; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D012878:Skin Neoplasms; D013668:Technetium Tc 99m Aggregated Albumin; D015899:Tomography, Emission-Computed, Single-Photon; D055815:Young Adult; D000096142:Cutaneous Malignant Melanoma
chemical_list: D004396:Coloring Agents; D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin; D007208:Indocyanine Green