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

Technische Universität Dresden

Status: Completed

Conditions: Non-melanoma Skin Cancer

Treatments: Device: optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography

Study type: Interventional

Funder types: Other

Identifiers

NCT05842421

IDNMSC

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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.