Trial document




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  DRKS00004622

Trial Description

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Title

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

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Trial Acronym

SLNE-Hybrid

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this randomized study, a hybrid tracers of technetium and indocyanine green should be investigated. This hybrid tracer is the combination of two substances with the aid of detecting two different qualities: radioactive and fluorescence.
It will be examined in this two-arm study how useful this combination marker during surgery and sentinel node lymph vessels in malignant skin cancer in the head and neck can be. The allocation to the two arms of the study carried out at random.
The markings applied before surgery can be compared with the marks during the operation by using the indocyanine green staining. It should further be made a comparison of the duration of surgery, and a cost analysis.

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Brief Summary in Scientific Language

In this prospective randomized study we will investigate the influence of the type of labeling (99mTechnetium + Indocyanin green vs. 99mTechnetium) on the detection rate of sentinel lymph nodes in the head and neck region, the rate of false negative sentinel node, the operation time and hospital costs.

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Organizational Data

  •   DRKS00004622
  •   2013/01/22
  •   [---]*
  •   yes
  •   Approved
  •   12-4972-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
  •   C44 -  Other malignant neoplasms of skin
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Interventions/Observational Groups

  •   Lymphoscintigraphy with 99m-technetium and intraoperative fluorescence detection of indocyanin green
  •   Lymphoscintigraphy with 99m-technetium
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
  •   Yes
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/25
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional 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.

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Exclusion Criteria

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

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Addresses

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    • Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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    • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Essen
    • Mr.  Dr.  Joachim  Klode 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Essen
    • Mr.  Dr.  Ingo  Stoffels 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/31
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Trial Publications, Results and other Documents

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