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

NCT05842421 | Completed

• 1 other identifier: IDNMSC
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Non-melanoma Skin Cancer

Keywords

dermoscopy; 3D total body photography; optical coherence tomography; in vivo reflectance confocal microscopy; total body photography; non-invasive imaging; confocal microscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer

  up to 24 months

• Diagnostic accuracy of 3D total body photography

  up to 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: participant and investigator, who does the clinical examination and planning of surgery are not blinded, but surgeons and pathologists are blinded to the groups
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, unicentric study

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: April 21, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)