Fast Track Diagnosis of Skin Cancer by Advanced Imaging

NCT04229277 | Completed DMC

• 1 other identifier: H-19036900
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of study: To collect data for a new image-guided diagnostic algoritm, enabling the investigators to differentiate more precisely between benign and malignant pigmented tumours at the bedside. This study will include 60 patients with four different pigmented tumours: seborrheic keratosis (n=15), dermal nevi (n=15), pigmented basal cell carcinomas (n=15), and malignant melanomas (n=15), these four types of tumours are depicted in Fig.1, and all lesions will be scanned by four imaging technologies, recruiting patients from Sept 2019 to May 2020. In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology

Conditions

Malignant Melanoma; Nevus, Pigmented; Basal Cell Carcinoma; Seborrheic Keratosis

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.

  Sensitivity is expressed in percentage and defines the proportion of true positive subjects with the disease in a total group of subjects with the disease (TP/TP+FN). Sensitivity is defined as the probability of getting a positive test result in subjects with the disease (T+\|B+). Specificity is a measure of diagnostic test´s accuracy, complementary to sensitivity. It is defined as a proportion of subjects without the disease with negative test result in total of subjects without disease (TN/TN+FP). Sensitivity and specificity are reported in percent

  6-12 months

Secondary Outcomes (6)

• tumour thickness

  6-12 months

• survival rates

  12 months

• blood flow in skin tumours

  6-12 months

• To report potential decreased time delay from first visit to efficient skin cancer treatment

  12 months

• To record treatment types and number of therapeutic sessions (e.g. operations)

  12 months

Study Arms (1)

in tumours

OTHER

consecutive enrollment of newly referred skin tumour patients

Diagnostic Test: optical coherence tomography

Interventions

optical coherence tomography DIAGNOSTIC_TEST

comparison of four imaging technologies in skin tumour diagnosis

Also known as: photoacoustic imaging, in vivo confocal microscopy, doppler ultrasound

in tumours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically verified: seborrheic keratosis 15 in total, dermal nevi 15 in total, pigmented BCC in total, and malignant melanomas 15 in total on areas of the body where scanning is feasible with all five systems
• Patients with skin tumours clinically suspicious of one of the four lesions mentioned in (1), that are not yet biopsied, if the patient is willing to undergo a skin biopsy from the suspicious lesion
• \> 18 years of age at baseline
• Legally competent, able to give verbal and written consent
• Communicate in Danish verbally as well as in writing
• Subject in good general health, is willing to participate and able to give informed consent and can comply with protocol requirements.

You may not qualify if:

• Individuals with other skin diseases in the skin area of interest
• Individuals who´s skin tumour is not accessible for imaging e.g. inside the ear, inside nostrils, on eyelids
• Subjects who will not undergo a skin biopsy after imaging of the suspicious tumour clinically diagnosed as BCC
• Pregnancy

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Dept of Dermatology

Copenhagen, dk-2400, Denmark

Location

MeSH Terms

Conditions

Melanoma; Nevus, Pigmented; Carcinoma, Basal Cell; Keratosis, Seborrheic

Interventions

Tomography, Optical Coherence; Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Nevus; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Keratosis

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass. Prof., Chief Consultant

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: September 9, 2019
• Primary Completion: March 22, 2021
• Study Completion: June 1, 2021
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)