Imaging Methods for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors

Study Overview
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Brief Summary
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Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors

Detailed Description
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250 patients with lesions that are suspicious for non-melanoma skin cancer that had not yet had a biopsy, are randomized in 2 groups. The intervention group is examined with total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy; the control group is examined with dermoscopy only. The aim of the study is to investigate whether these methods improve the early detection of non-melanoma skin cancer and their precursors. Examined are not only the differences in management of the lesions (excision, biopsy, local treatment or no treatment) and the diagnostic accuracy of the devices.

Official Title
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Imaging Methods Like Dermoscopy, Optical Coherence Tomography, in Vivo Reflectance Confocal Microscopy and 3D Total Body Photography for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors

Conditions
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Non-melanoma Skin Cancer

Intervention / Treatment
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* Device: optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions Exclusion Criteria: Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision Patients younger than 18 years Patients that are incapable of giving consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: randomized, controlled, unicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy, optical coherence tomography, in vivo reflectance confocal microscopy and each patient gets 3D total body photography. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups. | Device: optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography<br>* each lesion is in addition to examination with dermoscopy examined with optical coherence tomography, in vivo reflectance confocal microscopy, each patient is photographed with 3D total body photography<br>|
| No Intervention: Control group<br>After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy as is the standard of care. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of non-melanoma skin cancer | Is management of non-melanoma skin cancer optimized after using non-invasive imaging devices like optical coherence tomography, in vivo reflectance confocal microscopy in comparison to examination with dermoscopy alone (number of primary excisions, number of biopsies, number of secondary inpatient stays due to positive biopsies, number of local treatments and lesions in which no treatment is necessary) | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer | Comparison of diagnostic accuracy of dermoscopy and optical coherence tomography and invivo reflectance confocal microscopy (is diagnostic accuracy of optical coherence tomography better or confocal microscopy better than in dermoscopy alone? | up to 24 months | 
| Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer | Does the combination of the results of optical coherence tomography and in vivo reflectance confocal microscopy in each lesion lead to an even better diagnostic accuracy than each device alone? | up to 24 months | 
| Diagnostic accuracy of 3D total body photography | Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermoscopy, 3D total body photography, optical coherence tomography, in vivo reflectance confocal microscopy, total body photography, non-invasive imaging, confocal microscopy