Trial document




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  DRKS00008838

Trial Description

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Title

Cinicial trial to assess the two-photon microscope "VertiSCAN" (future "2PM VertiSCAN") in the in vivo and ex vivo diagnostics of melanocytic, mesenchymal and epithelial benign as malignant skin tumors (epidermis and upper cutis)

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Trial Acronym

VertiScan

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is currently still necessary in cases of suspected skin cancer to confirm the diagnosis, a tissue sample, if not a complete surgical removal of the tumor followed by pathological, ie histological assessment with a microscope.
To the future to enable a reliable assessment of the tumor without surgery, is studied in this clinical trial, whether the new, not yet approved imaging method "VertiSCAN" (an innovative laser technology) high-resolution images of the skin can be created on the computer screen prior to surgery to facilitate an assessment of the tumor.
These incision images are generated by laser, to permit an evaluation by deeper tissue layers. The images obtained are evaluated for their diagnostic relevance and compared with the results of the investigation on the microscope anyway then surgically removed tissue.

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Brief Summary in Scientific Language

The diagnosis of cutaneous as cutaneous-adnexaler changes epithelial, melanocytic and mesenchymal origin takes place in dermatology today mainly based on clinical experience and in tumors also by Dermo- or Videodermoskopie.
The "VertiSCAN" procedure provides a new imaging methodology in dermatology, which fall to a deep-resolution measurement for the first time in vivo as ex vivo assessment benign as malignant skin tumors and so allow skin diagnosis without sampling. In contrast to confocal fluorescence microscopy endogenous chromophores fluorescence images of the tissue depth are generated by a femtosecond laser using nonlinear excitation. These amounts are released laterally and axially through the tissue by optomechanical movement and allow such an assessment for the first time also from deeper tissue layers. There are generated in real-time serial incision images with penetration in the usual presentation of histological preparations.

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Organizational Data

  •   DRKS00008838
  •   2015/06/24
  •   [---]*
  •   yes
  •   Approved
  •   144/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1171-4232 
  •   CIV-13-09-011620 
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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

  •   The measuring head of the fluorescence scanner is fixed on the skin lesion to be examined on the patient.
    The lesion will be examined more than 20 minutes with a laser power of up to 50mW (before excesion in vivo)
    Then the tumor will be execised to standard guidelines and the fresh excidated tissue will be examined immediately after surgery also for max. 15 min. with "VertiSCAN" (ex vivo).
    Subsequent routine follow-up of tissue for histological assessment as usual.
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Characteristics

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

Is by "VertiSCAN" a sufficiently reliable in-vivo diagnosis of skin tumors possible
a. significantly correlated with the results of the subsequent examination of the tissue sample
b. and thus a tissue sample makes dispensable, at least in certain cases.

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Secondary Outcome

1. Is by "VertiSCAN" a sufficiently reliable ex-vivo diagnosis of skin tumors possible
a. significantly correlated with the results of the subsequent histological examination of the tissue sample
b. and the section diagnosis "on side"

2. obtain clinical information about ergonomics in hospital use, in order to create through technical improvements to the machine a clinically optimal usable diagnostic tool

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/02
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. Adults 18-80 years
2. clinical suspicion of an epithelial, melanocytic or mesenchymal tumor as basal cell carcinoma, Porom, Pinkus tumor, seborrheic keratosis, Melanoakantom, actinic keratosis grade I-III, squamous cell carcinoma, naevoid lentigo, Nevus, dysplastic nevus, early invasive melanoma, Merkel cell carcinoma, pleomorphic sarcoma or Dermatofibrosarkoma protuberans etc.
3. written consent after verbal intelligence

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Exclusion Criteria

1. lack of capacity to consent
2. Pregnancy and lactation
3. poor general condition (ECOC 3-4)
4. serious bacterial and mycotic infection
5. tumors in face localization or to the scalp

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Addresses

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    • Otto-von-Guericke Universität MagdeburgMedizinische Fakultät
    • Mr.  Prof. Dr. med.  Hermann-Josef  Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • W.O.M. World of Medicine GmbH
    • Mr.  Dr.  Karl-Heinz  Schönborn 
    • Salzufer 8
    • 10587  Berlin
    • Germany
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    • Klinik für Dermatologie und Allergologie, UKGM Gießen/Marburg, Standort Gießen
    • Ms.  PD OA Dr. med.  Daniela  Göppner 
    • Gaffykstrasse 14
    • 35392  Gießen
    • Germany
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    • Klinik für Dermatologie und Allergologie, UKGM Unikliniken Gießen/Marburg, Standort Gießen
    • Ms.  PD OA Dr. med.  Daniela  Göppner 
    • Gaffykstrasse 14
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • W.O.M. World of Medicine GmbH
    • Mr.  Dr.  Karl-Heinz  Schönborn 
    • Salzufer 8
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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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.