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

NCT ID: NCT05389085

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-07-31

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

Conditions

Skin Cancer; Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prospective non-blinded clinical study

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.

Group Type: OTHER

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Vivascope Multilaser 1500®, Vivascope GmbH, Munich, Germany, https://www.vivascope.de/medical-imaging/ and provided in Denmark by Scan-Med A/S, Dalgårdsvej 17, 8220 Brabrand.; MSOT Acuity from iThera Medical GmbH, Munich, Germany, https://www.ithera-medical.com/technology/ not sold in Denmark but provided directly from the company.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Mette Mogensen

Assoc. Prof, Chief Consultant, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Mogensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Dept of Dermatology

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2200972

Identifier Type: -

Identifier Source: org_study_id