Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged \> 18 years

• Willingness to participate in this study including the assessment with high resolution OCT

• Skin lesion/tumor with suspicion for skin cancer that requires skin biopsy or complete excision

• Benign skin tumor that is scheduled for excision due to suspicion, irritation or for cosmetic reason

Locations
Other Locations
Germany
CMB COLLEGIUM MEDICUM BERLIN GmbH
RECRUITING
Berlin
Contact Information
Primary
Emily Tsai, PhD
emily@mdamo.com
886-2-87523198
Backup
Hsin Cheng
hsin@mdamo.com
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2025-02
Participants
Target number of participants: 200
Treatments
Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors
Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors who are scheduled for skin biopsy or excision
Related Therapeutic Areas
Sponsors
Leads: Apollo Medical Optics, Ltd

This content was sourced from clinicaltrials.gov