"Fluorescence labeling using indocyanine green in the sentinel lymph node excision. Clinical evaluation of the Fluobeam system"

"Fluorescence labeling using indocyanine green in the sentinel lymph node excision. Clinical evaluation of the Fluobeam system" - SLNE-NRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004619

Enrollment

Registered

2013-01-28

Start date

2013-01-28

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

Interventions

Group 1: Sentinel lymph node biopsy: lymphoscintigraphy with 99m Technetium and visualization of Indocyanin green with the Fluobeam800 system.

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a malignant melanoma at the trunk or extremities, stage Ib and II (AJCC 2009)

Exclusion criteria

Exclusion criteria: Age < 18 years, Indocyaningreen intolerance, iodine allergy

Design outcomes

Primary

Measure	Time frame
Rate of sentinel positivity	—

Secondary

Measure	Time frame
False negative rate, surgery duration, mean number of SNs excised per patient using both methods, Determine the costs of both methods	—

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: Mar 4, 2026