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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389085
• Other study ID #: 2200972
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Skin Cancer
• Skin Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dept of Dermatology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	All patients will be scanned by an experienced examiner in a 30 minutes to 1 hour session.
Secondary	Analysis of RNA molecules of surface cells from tape stripping	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).	Up to 6 months
Secondary	Lipid analysis from tape-stripping	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.	Up to 6 months