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

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ClinicalTrials.gov Identifier: NCT05389085
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Mette Mogensen, 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.

Condition or disease Intervention/treatment Phase
Skin Cancer Malignant Melanoma Diagnostic Test: Reflectance confocal microscopy (RCM), Photoacoustic imaging (PAI) and tape-strippng of RNA and lipids Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This prospective non-blinded clinical study will include 75 patients with suspicious pigmented skin tumours (i.e. malignant melanomas, lentigo maligna, pigmented nevi, and pigmented basal cell carcinomas) referred to or diagnosed at Dept. of Dermatology, BFH. All tumours are histologically verified by skin biopsy or surgical excision. Patients who meet the inclusion criteria will be enrolled if they consent. If patients demonstrate more than one skin tumour within the same anatomical location, only one lesions will be included and scanned.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fast Track Diagnosis of Malignant Melanoma by Two Advanced Imaging Technologies and Tumour Tapestripping of RNA and Lipids
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
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.
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.
Other 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. Analysis of RNA molecules of surface cells from tape stripping [ Time Frame: 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).

  2. Lipid analysis from tape-stripping [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389085


Contacts
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Contact: Mette Mogensen, MD, PhD +45 30914568 mette.mogensen.01@regionh.dk
Contact: Terese von Knorring, MD +45 28261325 teresevonknorring@gmail.com

Locations
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Denmark
Dept of Dermatology Recruiting
Copenhagen, Denmark, dk-2400
Contact: mette mogensen, MD, PhD    +45 31904568    mette.mogensen.01@regionh.dk   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Investigators
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Principal Investigator: Mette Mogensen, MD, PhD Bispebjerg Hospital
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Responsible Party: Mette Mogensen, Assoc. Prof, Chief Consultant, MD, PhD, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT05389085    
Other Study ID Numbers: 2200972
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The study will be performed in accordance with ICH GCP Guidelines and Danish Health care authorities. It will be registered at The National Committee on Health Research Ethics, Danish Medicines Agency, and The Danish Data Protection Agency. Study conduction and reports are in accordance with GCP CPMP/ICH/135/95 and European Medicines Agency directive 2001/83/EC.

The study will be published in an international dermatological journal and presented at scientific conferences. Positive, negative and inconclusive results will be published and inconclusive results will be published at www.clinicaltrials.gov and www.clinicaltrialsregister.eu . Authorships are given according to the Vancouver guidelines.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mette Mogensen, University Hospital Bispebjerg and Frederiksberg:
diagnostic imaging
pigmented skin neoplasm
tape-stripping
photoacoustic techniques
confocal microscopy
Additional relevant MeSH terms:
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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases