Trial document




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  DRKS00005447

Trial Description

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Title

"Photoacoustic tomography (PAT) in combination with high resolution ultrasound for non-invasive diagnosis of sentinel lymph node in patients with malignant melanoma"

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Trial Acronym

SentinelPAT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For sentinel lymph node removal for spreading diagnosis of malignant melanoma, the lymph nodes are radiolabeled prior to surgery by the lymphoscintigraphy. This examination will receive all patients. Additionally in this study, a marking of the lymph nodes is performed with a dye before the operation. Nationally and internationally, the fluorescent dye indocyanine green (ICG) is used as an additional marker option. In this study an additional new method for identification of the marked nodes will now be examined. It is used in addition to the actual gold standard of marking sentinel lymph nodes.
This means that the fluorescent dye labeled lymph nodes, can be identified through the skin. Maybe in the future it can be dispensed with a radioactive label.
The technique is called photo-acoustic tomography, combining a conventional ultrasound examination with a laser. During the examination, laser protective goggles are worn. A risk of adverse effects does not exist. In our study, the results of the labeling method and the standard pathology are compared with the new method.
The examination is embedded in the normal course of the sentinel lymph node removal and prolongs the intervention only insignificantly.

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Brief Summary in Scientific Language

The aim of this prospective trial is to analyze an innovative, noninvasive and non-radioactive staging tool to determine the sentinel lymph node status of melanoma patients using photoacoustic tomography (PAT) imaging with high-resulution ultrasound in combination with indocyanin green (ICG)-injection.
For this purpose the data of preoperative in vivo PAT diagnostic should be compared with the findings in vivo. Postoperative ex vivo diagnostics using PAT should be compared with subsequent histology.

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Organizational Data

  •   DRKS00005447
  •   2013/11/12
  •   [---]*
  •   yes
  •   Approved
  •   13-5468-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1150-1567 
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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Preoperative sentinel lymph node (SLN) in vivo detection with Indocyanin green (ICG) and photoacoustic tomography and postoperative ex vivo PAT examination of the SLN and histology.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Detectionrate of the fluorescent SLN prior to surgery by photoacoustic tomography

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Secondary Outcome

Detectionrate of the SLN melanin signal by photoacoustic tomography

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/02
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with a malignant melanoma
- stages Ib and II (AJCC 2009)
- age > 18 years

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Exclusion Criteria

- age < 18 years
- known intolerance to ICG
- iodine allergy

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Addresses

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

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    • Universitätsklinikum Essen Klinik für Dermatologie und Venerologie
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.