Clinical trial NCT05389085: Fast Track Diagnosis of Skin Cancer by Advanced Imaging Technologies and Tumour Tapestripping
Official title: Fast Track Diagnosis of Malignant Melanoma by Two Advanced Imaging Technologies and Tumour Tapestripping of RNA and Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Malignant Melanoma
Keywords: diagnostic imaging
pigmented skin neoplasm
tape-stripping
photoacoustic techniques
confocal microscopy
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective non-blinded clinical study will include 75 patients with suspicious pigmented skin tumours (i.e. malignant melanomas, lentigo maligna, pigmented nevi, and pigmented basal cell carcinomas) referred to or diagnosed at Dept. of Dermatology, BFH. All tumours are histologically verified by skin biopsy or surgical excision. Patients who meet the inclusion criteria will be enrolled if they consent. If patients demonstrate more than one skin tumour within the same anatomical location, only one lesions will be included and scanned.
Primary purpose: DIAGNOSTIC

Brief summary: In this clinical feasibility study the investigators will test and compare two advanced optical imaging technologies, lipid and RNA tape stripping with regards to diagnostic accuracies for fast bedside diagnosis of pigmented skin tumours.

Detailed description: This original clinical research project utilizes cutting-edge medical imaging technologies for diagnosis of pigmented skin tumours, combined for the first time in Denmark, with molecular RNA and lipid analysis of superficial tumours cells. The scanning technologies are reflectance confocal microscopy (RCM), which is a microscope applied directly to the skin surface, and photoacoustic imaging, also termed multispectral optoacoustic imaging (MSOT), which is an imaging technology actually listening to the skin for immediate bedside diagnosis of pigmented skin tumors. The hypothesis is that treatment guided by diagnostic bedside skin scanning, combined with tumour tape-stripping and RNA and lipid analysis can increase diagnostic accuracy compared to visual inspection of the skin tumour and thus decrease time delay from diagnosis to efficient treatment

Eligibility criteria: Inclusion Criteria:

1. 75 patients with histologically verified pigmented skin tumours on areas of the body where scanning is feasible with both imaging systems
2. Patients with clinically suspicious skin tumours, that are not yet biopsied, if the patient is willing to undergo a skin biopsy from the suspicious lesion
3. \> 18 years of age at baseline
4. Legally competent, able to give verbal and written consent
5. Communicate in Danish verbally as well as in writing
6. Subject in good general health, is willing to participate and able to give informed consent and can comply with protocol requirements.

Exclusion Criteria:

1. Individuals with other skin diseases in the skin area of interest
2. Individuals who´s skin tumour is not accessible for imaging e.g. inside the ear, inside nostrils, on eyelids
3. Subjects who will not undergo a skin biopsy after imaging of the suspicious skin tumour and who have not had a skin biopsy taken from the tumour prior to referral
4. Pregnancy
5. Women of child-bearing potential not using a contraceptive agent at the time of inclusion

Primary outcomes:
measure: Diagnostic accuracy. The primary objective i to test and compare two advanced optical imaging technologies, lipid and RNA tape stripping with regards to diagnostic accuracies for fast bedside diagnosis of pigmented skin tumours.
timeFrame: All patients will be scanned by an experienced examiner in a 30 minutes to 1 hour session.
Secondary outcomes:
measure: Analysis of RNA molecules of surface cells from tape stripping
timeFrame: Up to 6 months
measure: Lipid analysis from tape-stripping
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of Dermatology
Study officials:
affiliation: Bispebjerg Hospital
name: Mette Mogensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: