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

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 - SLNE-Hybrid

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004622

Enrollment

Registered

2013-01-22

Start date

2013-01-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C43 C44

Interventions

Group 1: Lymphoscintigraphy with 99m-technetium and intraoperative fluorescence detection of indocyanin green Group 2: Lymphoscintigraphy with 99m-technetium

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age < 18 years, Indocyanin green intolerance, iodine allergy.

Design outcomes

Primary

Measure	Time frame
Rate of SN positivity in the two arms, examined by histopathology after the operative procedure	—

Secondary

Measure	Time frame
False negative rate in the two arms (Local relapse within 1 year after the sentinel lymph node excision); 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	—

Countries

Germany

Contacts

Public ContactIngo Stoffels

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Essen

ingo.stoffels@uk-essen.de0201-723-3642

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026