Actively Recruiting

Age: 18Years +
All Genders
ID05068310

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

Led by Apollo Medical Optics, Ltd · Updated on 2024-12-31

200

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Skin cancer cases, including both melanoma and non-melanoma types, have been steadily rising over recent decades. This research investigates new imaging technologies to improve the diagnosis of pigmented and non-pigmented skin tumors without needing invasive biopsies. The study evaluates the use of a high-resolution optical coherence tomography (OCT) scanner, the ApolloVueae S100 Image System, which offers detailed skin imaging at the cellular level and combines advantages of existing imaging methods like confocal microscopy and traditional OCT. The study uses the ApolloVueae S100, a CE-certified device that produces two-dimensional, cross-sectional, and en-face images of the skin in real time. This system employs a special light source and camera to create high-speed, high-resolution images, allowing precise examination of skin lesions. Other imaging devices such as confocal microscopy, Vivascopeae, Vivosightae OCT, and dermoscopy with DermLite FotoXae are also used for comparison on a subset of skin lesions. The system's guiding mechanism helps position the probe accurately for detailed scans during the study. Participants with pigmented or non-pigmented skin lesions scheduled for biopsy or excision will undergo imaging assessments using these devices. Researchers will characterize disease features and evaluate diagnostic accuracy over approximately 1.5 years. Data collected includes OCT images, lesion positions, and clinical assessments. This non-invasive imaging study aims to improve skin tumor evaluation while reducing unnecessary biopsies, with no additional treatments given. Participants' progress and skin lesion images will be monitored and recorded throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged > 18 years
  • Willingness to participate in this study including the assessment with high resolution OCT
  • Skin lesion or tumor suspected for skin cancer that requires skin biopsy or complete excision
  • Benign skin tumor scheduled for excision due to suspicion, irritation, or cosmetic reasons
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1.5 years

Participants undergo non-invasive imaging of skin lesions using several devices including a high resolution full-field OCT system, confocal microscopy, optical coherence tomography imaging, and dermoscopy imaging for assessment.

Visits as scheduled for imaging and assessments depending on lesion evaluation

Long-term Monitoring

Duration - Up to 1.5 years

Participants with pigmented and non-pigmented skin lesions are monitored through imaging and clinical follow-up to characterize disease features and diagnostic accuracy over time.

Follow-up visits depending on clinical need and assessment schedule

Trial Site Locations

Total: 1 location

1

CMB COLLEGIUM MEDICUM BERLIN GmbH

Berlin, Germany

Actively Recruiting

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Research Team

E

Emily Tsai, PhD

H

Hsin Cheng

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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