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)
Not Applicable
- Conditions
- C43C44Malignant melanoma of skinOther malignant neoplasms of skin
- Registration Number
- DRKS00008838
- Lead Sponsor
- Otto-von-Guericke Universität MagdeburgMedizinische Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is by VertiSCAN a sufficiently reliable in-vivo diagnosis of skin tumors possible<br>a. significantly correlated with the results of the subsequent examination of the tissue sample <br>b. and thus a tissue sample makes dispensable, at least in certain cases.
- Secondary Outcome Measures
Name Time Method 1. Is by VertiSCAN a sufficiently reliable ex-vivo diagnosis of skin tumors possible<br>a. significantly correlated with the results of the subsequent histological examination of the tissue sample <br>b. and the section diagnosis on side<br><br>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