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Fast Track Diagnosis of Skin Cancer by Advanced Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229277
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mette Mogensen, University Hospital Bispebjerg and Frederiksberg

Brief Summary:

Aim of study:

To collect data for a new image-guided diagnostic algoritm, enabling the investigators to differentiate more precisely between benign and malignant pigmented tumours at the bedside. This study will include 60 patients with four different pigmented tumours: seborrheic keratosis (n=15), dermal nevi (n=15), pigmented basal cell carcinomas (n=15), and malignant melanomas (n=15), these four types of tumours are depicted in Fig.1, and all lesions will be scanned by four imaging technologies, recruiting patients from Sept 2019 to May 2020. In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology


Condition or disease Intervention/treatment Phase
Malignant Melanoma Nevus, Pigmented Basal Cell Carcinoma Seborrheic Keratosis Diagnostic Test: optical coherence tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fast Track Diagnosis of Skin Tumours by Four Different Advanced Imaging Technologies - a Clinical Study
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : March 22, 2020
Estimated Study Completion Date : June 1, 2020


Arm Intervention/treatment
in tumours
consecutive enrollment of newly referred skin tumour patients
Diagnostic Test: optical coherence tomography
comparison of four imaging technologies in skin tumour diagnosis
Other Names:
  • photoacoustic imaging
  • in vivo confocal microscopy
  • doppler ultrasound




Primary Outcome Measures :
  1. diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours. [ Time Frame: 6-12 months ]
    Sensitivity is expressed in percentage and defines the proportion of true positive subjects with the disease in a total group of subjects with the disease (TP/TP+FN). Sensitivity is defined as the probability of getting a positive test result in subjects with the disease (T+|B+). Specificity is a measure of diagnostic test´s accuracy, complementary to sensitivity. It is defined as a proportion of subjects without the disease with negative test result in total of subjects without disease (TN/TN+FP). Sensitivity and specificity are reported in percent


Secondary Outcome Measures :
  1. tumour thickness [ Time Frame: 6-12 months ]
    in millimeters

  2. survival rates [ Time Frame: 12 months ]
    in number of months

  3. blood flow in skin tumours [ Time Frame: 6-12 months ]
    expressed in arbitrary units in OCT volume scans and in volume densities/second in doppler ultrasound images

  4. To report potential decreased time delay from first visit to efficient skin cancer treatment [ Time Frame: 12 months ]
    Expressed as duration of time from diagnosis till initial treatment in number of days

  5. To record treatment types and number of therapeutic sessions (e.g. operations) [ Time Frame: 12 months ]
    For each study participant treatment types are listed in numerical numbers and so is the number of treatment sessions counted and listed for each individual participant in this trial

  6. To report patient satisfaction of scanning procedures [ Time Frame: 6-12 months ]
    A questionnaire with qualitative questions (How did you like being scanned?) and quantitative questions: on a scale from 0-10 how painful was the scanning procedure)



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. 60 Patients with histologically verified: seborrheic keratosis 15 in total, dermal nevi 15 in total, pigmented BCC in total, and malignant melanomas 15 in total on areas of the body where scanning is feasible with all five systems
  2. Patients with skin tumours clinically suspicious of one of the four lesions mentioned in (1), 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 tumour clinically diagnosed as BCC
  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): NCT04229277


Locations
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Denmark
Dept of Dermatology
Copenhagen, Denmark, dk-2400
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg

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Responsible Party: Mette Mogensen, MD, PhD, Ass. Prof., Chief Consultant, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04229277    
Other Study ID Numbers: H-19036900
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The images file data will be very large and will be situated on the hospital server. We cannot legally share these files.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Melanoma
Carcinoma, Basal Cell
Nevus, Pigmented
Nevus
Keratosis
Keratosis, Seborrheic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Basal Cell