High-resolution imaging for skin tumors using advanced optical technology
Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors
Apollo Medical Optics, Ltd · NCT05068310
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 type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Apollo Medical Optics, Ltd (industry) |
| Drugs / interventions | cart |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05068310 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with skin lesions suspected of being cancerous or benign tumors requiring excision.
Not a fit: Patients under 18 or those with unstable medical or psychological conditions may not benefit from this study.
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 performed: Previous studies have shown success with similar imaging technologies in dermatology, indicating potential for this novel approach.
Eligibility criteria
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 this trial is running
Berlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin Lesion, Skin Cancer