Status:

COMPLETED

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

Lead Sponsor:

University Hospital Bispebjerg and Frederiksberg

Conditions:

Skin Cancer

Malignant Melanoma

Eligibility:

All Genders

18+ years

Phase:

NA

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 bedsid...

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...

Eligibility Criteria

Inclusion

  • 75 patients with histologically verified pigmented skin tumours on areas of the body where scanning is feasible with both imaging systems
  • 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
  • \> 18 years of age at baseline
  • Legally competent, able to give verbal and written consent
  • Communicate in Danish verbally as well as in writing
  • Subject in good general health, is willing to participate and able to give informed consent and can comply with protocol requirements.

Exclusion

  • Individuals with other skin diseases in the skin area of interest
  • Individuals who´s skin tumour is not accessible for imaging e.g. inside the ear, inside nostrils, on eyelids
  • 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
  • Pregnancy
  • Women of child-bearing potential not using a contraceptive agent at the time of inclusion

Key Trial Info

Start Date :

May 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2022

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT05389085

Start Date

May 1 2022

End Date

July 31 2022

Last Update

May 9 2023

Active Locations (1)

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1

Dept of Dermatology

Copenhagen, Denmark, dk-2400