Fast Track Diagnosis of Skin Cancer by Advanced Imaging (NCT04229277) | Clinical Trial Compass
CompletedNot Applicable
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
Denmark41 participantsStarted 2019-09-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 60 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.
Exclusion criteria
✕. 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
What they're measuring
1
diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.
Timeframe: 6-12 months
Trial details
NCT IDNCT04229277
SponsorUniversity Hospital Bispebjerg and Frederiksberg