Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors

NCT05068310 | Recruiting FDA Device

• 1 other identifier: 21SDE2-01-001-V1A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Lesion; Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Characterization of the disease features of pigmented and non-pigmented skin lesions

  This is an observational study. The morphologic patterns of pigmented and non-pigmented skin lesions will be examined (% lesions that demonstrate descriptor examined).

  1.5 year

Secondary Outcomes (1)

• Diagnostic accuracy of pigmented and non-pigmented skin lesions

  1.5 year

Study Arms (1)

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

Device: Cellular resolution full-field optical coherence tomography; Device: Confocal microscopy; Device: Optical coherence tomography imaging; Device: Dermoscopy imaging

Interventions

Cellular resolution full-field optical coherence tomography DEVICE

Device: ApolloVue® S100 Image System

Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors

Confocal microscopy DEVICE

Device: Vivascope® will be used for skin imaging for a subset of skin lesions.

Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors

Optical coherence tomography imaging DEVICE

Device: Vivosight® will be used for skin imaging for a subset of skin lesions.

Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors

Dermoscopy imaging DEVICE

Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®

Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicious skin lesion/tumor that requires skin biopsy or complete excision

You may qualify if:

• 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

You may not qualify if:

• Patients aged \< 18 years
• Any unstable medical or psychological conditions
• Unwillingness to participate in this study including the assessment with high resolution OCT

Sponsors & Collaborators

• Apollo Medical Optics, Ltd: lead

Study Sites (1)

CMB COLLEGIUM MEDICUM BERLIN GmbH

Berlin, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin tissue biopsy

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Martina Ulrich, MD

  CMB COLLEGIUM MEDICUM BERLIN GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Tsai, PhD

CONTACT

886-2-87523198; emily@mdamo.com

Hsin Cheng

CONTACT

hsin@mdamo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 5, 2021
• Study Start: October 21, 2021
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

DE (1)