NCT05389085

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

Fast Track Diagnosis of Malignant Melanoma by Two Advanced Imaging Technologies and Tumour Tapestripping of RNA and Lipids

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Skin Cancer
• Malignant Melanoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids	In vivo RCM will be used to diagnose pigmented tumours at a cellular level and provide information on skin microarchitecture. MSOT detects skin chromophores as melanin, hemoglobin, water, collagen, and lipids, which will be included in analysis of diagnostic accuracies. MSOT will also be used to measure tumour thickness; delineate tumour borders and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. RNA and lipid profiles from tape stripping results will be compared to imaging and histopathology diagnosis.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2022-05-24
• Last updated: 2023-05-09

Locations

1 site across 1 country: Denmark