Clinical trial Recruiting at 1 site Observational Ages 18 and up

High-resolution imaging for skin tumors using advanced optical technology

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

Run by Apollo Medical Optics, Ltd · NCT05068310 · Data updated 2026-11-12

This study is testing a new imaging system to see if it can help doctors better diagnose skin tumors without needing to do painful biopsies.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorApollo Medical Optics, Ltd
Industry-sponsored
Drugs / interventionscart
Locations1 site (Berlin)
StatusRecruiting
StartedOctober 21, 2021
Main results expectedJanuary 2025
Study endsFebruary 2025
Registry record updatedDecember 31, 2024
Trial IDNCT05068310 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with skin lesions suspected of being cancerous or benign tumors requiring excision.

Probably not a fit

Patients under 18 or those with unstable medical or psychological conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new high-resolution optical coherence tomography (OCT) system for diagnosing pigmented and non-pigmented skin tumors. The ApolloVue® S100 Image System allows non-invasive, real-time imaging of skin lesions at a cellular level, potentially reducing the need for invasive biopsies. By providing detailed cross-sectional and en-face images, this technology aims to enhance the accuracy of skin cancer diagnoses. The study will involve patients with skin lesions that are suspected to be cancerous or benign but require further examination.

Why it matters

Potential benefit: If successful, this technology could lead to more accurate diagnoses of skin tumors and reduce unnecessary biopsies.

How similar studies have gone: Previous studies have shown success with similar imaging technologies in dermatology, indicating potential for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

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

Where it's running

  • CMB COLLEGIUM MEDICUM BERLIN GmbH
    Berlin, Germany
    Recruiting

Study contacts

  • Principal investigator: Martina Ulrich, MD — CMB COLLEGIUM MEDICUM BERLIN GmbH
  • Study coordinator: Emily Tsai, PhD
  • Email: emily@mdamo.com
  • Phone: 886-2-87523198

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.