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

Not Applicable

Completed

• Conditions: Skin Cancer; Malignant Melanoma
• Interventions: Diagnostic Test: Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids

• Registration Number: NCT05389085
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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

Study Timeline

• Study First Submitted: 2022-04-28
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-24
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective non-blinded clinical study	Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids	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.

Primary Outcome Measures

Name	Time	Method
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.	All patients will be scanned by an experienced examiner in a 30 minutes to 1 hour session.	Will be presented as sensitivity, specificity, and positive and negative predictive values. Tumor thickness measurements using MSOT will be measured and reported in millimeters. The blood flow in dermal blood vessels will be measured quantitatively by MSOT and vascular morphology will be described qualitatively. RCM images will be evaluated qualitatively regarding cellular changes, skin micromorphology and characteristic malignant melanoma features.

Secondary Outcome Measures

Name	Time	Method
Lipid analysis from tape-stripping	Up to 6 months	We will analyze lipids obtained by tape-stripping from surface cells in pigmented lesions by ex vivo spectroscopic near-infrared optical coherence tomography (OCT), performed at DTU: Dept of Photonics Lab Facilities.
Analysis of RNA molecules of surface cells from tape stripping	Up to 6 months	Examination of the expression of a total of 22 selected RNA molecules in suspicious skin tumours will be investigated by quantitative reverse-transcription methods with the use of the TaqMan method (Thermo Fisher Scientific).

Trial Locations

Locations (1)

Dept of Dermatology; 🇩🇰 Copenhagen, Denmark