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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)

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) - VertiScan

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008838
Enrollment
300
Registered
2015-06-24
Start date
2019-06-02
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 C44

Interventions

Group 1: 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 (be

Sponsors

Otto-von-Guericke Universität MagdeburgMedizinische Fakultät
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactDaniela Göppner

Klinik für Dermatologie und Allergologie, UKGM Unikliniken Gießen/Marburg, Standort Gießen

daniela.göppner@med.ovgu.de+49-641-98559089

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026