Fast Track Diagnosis of Skin Cancer by Advanced Imaging Technologies and Tumour Tapestripping

University Hospital Bispebjerg and Frederiksberg

Status: Completed

Conditions: Malignant Melanoma; Skin Cancer

Treatments: Diagnostic Test: Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids

Study type: Interventional

Funder types: Other

Identifiers

NCT05389085

2200972

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Prospective non-blinded clinical study

Other group

Description:

All patients enrolled with with suspicious pigmented skin tumours will be scanned with reflectance confocal microscopy and photoacoustic imaging by an experienced examiner in a 30 minutes to 1-hour session. Subsequently, material for RNA and lipid analysis is obtained from tape-stripped lesional skin at the bedside. The skin tumors in patients enrolled will subsequently be treated according to hospital and national guidelines.

Treatment:

Diagnostic Test: Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids