Sentinel lymph node excision in the head and neck area for cutaneous malignancies: clinical evaluation of a hybrid tracer (technetium and indocyanine) versus technetium labeling

Not Applicable

• Conditions: C43; Other malignant neoplasms of skin; C44; Malignant melanoma of skin

• Registration Number: DRKS00004622
• Lead Sponsor: niversitätsklinikum Essen,Klinik für Dermatologie und Venerologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-22
• Study Completion: 2014-12-31
• Results First Posted: 2015-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age >18 years. Patients with a malignant melanoma in the head and neck area (stage IB and II; AJCC 2009). Patients with a squamousus cell carcinom in the head and neck (tumor thickness >4mm). Patients with a Merkel cell carcinom in the head and neck area.

Exclusion Criteria

Age < 18 years, Indocyanin green intolerance, iodine allergy.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of SN positivity in the two arms, examined by histopathology after the operative procedure

Secondary Outcome Measures

Name	Time	Method
False negative rate in the two arms (Local relapse within 1 year after the sentinel lymph node excision);<br>Difference in morbidity in terms of complication rate (clinical examination within the postopertive phase). Duration of surgery (in minutes); Number of excised lymph nodes per patient (operative report); Surgery costs