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

Not Applicable

Completed

• Conditions: Non-melanoma Skin Cancer
• Interventions: Device: optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography

• Registration Number: NCT05842421
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-21
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Status Verified: 2023-04
• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography	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.

Primary Outcome Measures

Name	Time	Method
Management of non-melanoma skin cancer	up to 24 months	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)

Secondary Outcome Measures

Name	Time	Method
Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer	up to 24 months	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?
Diagnostic accuracy of 3D total body photography	up to 24 months	Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy
Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer	up to 24 months	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?

Trial Locations

Locations (1)

Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany