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Fast Track Diagnosis of Skin Cancer by Advanced Imaging

Primary Purpose

Malignant Melanoma, Nevus, Pigmented, Basal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
optical coherence tomography
Sponsored by
University Hospital Bispebjerg and Frederiksberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

in tumours

Arm Description

consecutive enrollment of newly referred skin tumour patients

Outcomes

Primary Outcome Measures

diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.
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

tumour thickness
in millimeters
survival rates
in number of months
blood flow in skin tumours
expressed in arbitrary units in OCT volume scans and in volume densities/second in doppler ultrasound images
To report potential decreased time delay from first visit to efficient skin cancer treatment
Expressed as duration of time from diagnosis till initial treatment in number of days
To record treatment types and number of therapeutic sessions (e.g. operations)
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
To report patient satisfaction of scanning procedures
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)

Full Information

First Posted
January 9, 2020
Last Updated
November 2, 2020
Sponsor
University Hospital Bispebjerg and Frederiksberg
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1. Study Identification

Unique Protocol Identification Number
NCT04229277
Brief Title
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
Official Title
Fast Track Diagnosis of Skin Tumours by Four Different Advanced Imaging Technologies - a Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
March 22, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Bispebjerg and Frederiksberg

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Study design The prospective non-blinded clinical study will include with seborrheic keratosis (n=15), dermal nevi (n=15), pigmented or dark basal cell carcinomas (n=15), and malignant melanomas (n=15) referred to or diagnosed at Dept. of Dermatology, Bispebjerg Hospital. All tumours are histologically verified by skin biopsy. To explore clinical feasibility and diagnostic accuracy of four different skin imaging technologies all patients will be scanned by an experienced examiner in one 2-hour session. If patients demonstrate more than one skin tumour within the same anatomical location, all lesions will be included and scanned. Lesions in other anatomical areas of the same patient will not be included. The total extra time spend in the department to participate in this study will be approximately 2-3 hours for each patient. Only one visit is required to participate. The skin tumors in patients enrolled will subsequently be treated according to hospital and national guidelines. Background: A bedside examination of a skin tumours using advanced imaging technology is considered a valuable future tool for Dermatologists. The investigators vision is to provide image guided skin cancer therapy to all patients with skin tumours. This study compares clinical feasibility and diagnostic accuracy of four different imaging technologies applied in a fast-track bedside analysis of various skin tumours; four different types, 2 benign and 2 malignant types. It is also hypothesized that: Due to higher resolution UHR-OCT may have higher diagnostic accuracy than C-OCT. Doppler HIFU and optoacustic imaging diagnosis may be more accurate in skin tumours thicker than 1-2 mm compared to diagnosis based on OCT imaging. The cellular resolution of RCM and the detailed blood flow information acquired from photoacustic imaging may supplement clinical decision making and increase diagnostic accuracy compared to only OCT or only HIFU. Study objectives Primary objective: This study explores the clinical utility of four skin imaging technologies: scanning time, clinical feasibility (does the skin tumour fit into the scanning probe) and diagnostic accuracy. The investigators examine patients with four different common skin tumour types referred to Dept of Dermatology, BFH using four different advanced imaging technologies; five different tools as investigators apply two different OCT-systems. Secondary outcome measures: To measure diagnostic accuracy of index tests (OCT, RCM, HIFU and photoacoustic imaging) To measure tumor size by OCT, photoacoustic imaging and HIFU To explore if UHR-OCT detects features in tumors that C-OCT cannot detect. To explore if information from dynamic C-OCT images of dermal blood vessels inside the skin tumour increases diagnostic accuracy To explore if information from doppler ultrasound images of dermal vessels inside the tumour increases diagnostic accuracy To explore if information from photoacoustic imaging of dermal vessels inside the tumour increases diagnostic accuracy To report potential decreased time delay from first visit to efficient skin cancer treatment To record survival rates To record treatment types and number of therapeutic sessions (e.g. operations) To report potential adverse device events To report patient satisfaction of scanning procedures Evaluation of skin tumours All skin tumours will be evaluated clinically, by two different OCT systems (C-OCT and UHR-OCT), by RCM, by photoacoustic imaging and doppler HIFU. Skin biopsies will be performed according to standard hospital procedures. Skin punch biopsies from skin tumours are required for treatment planning and is not part of this research project. Accordingly, a skin biopsy will be performed as part of the treatment plan independent of whether the patient is recruited or not. Imaging Technologies 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 lesion types will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology The imaging methods OCT, RCM and doppler ultrasound, are technologies that are routinely used in the clinic at Dept of Dermatology, BFH and all investigators are highly trained in using the scanners. The UHR-OCT is a prototype and the photoacoustic system is a brand-new clinical device. OCT, RCM and ultrasound examinations are performed in a darkened room. The images of all patients will be saved in a digital archiving computer system for subsequent scoring and further evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma, Nevus, Pigmented, Basal Cell Carcinoma, Seborrheic Keratosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
in tumours
Arm Type
Other
Arm Description
consecutive enrollment of newly referred skin tumour patients
Intervention Type
Diagnostic Test
Intervention Name(s)
optical coherence tomography
Other Intervention Name(s)
photoacoustic imaging, in vivo confocal microscopy, doppler ultrasound
Intervention Description
comparison of four imaging technologies in skin tumour diagnosis
Primary Outcome Measure Information:
Title
diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.
Description
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
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
tumour thickness
Description
in millimeters
Time Frame
6-12 months
Title
survival rates
Description
in number of months
Time Frame
12 months
Title
blood flow in skin tumours
Description
expressed in arbitrary units in OCT volume scans and in volume densities/second in doppler ultrasound images
Time Frame
6-12 months
Title
To report potential decreased time delay from first visit to efficient skin cancer treatment
Description
Expressed as duration of time from diagnosis till initial treatment in number of days
Time Frame
12 months
Title
To record treatment types and number of therapeutic sessions (e.g. operations)
Description
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
Time Frame
12 months
Title
To report patient satisfaction of scanning procedures
Description
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)
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 > 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 Criteria: 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 tumour clinically diagnosed as BCC Pregnancy Women of child-bearing potential not using a contraceptive agent at the time of inclusion
Facility Information:
Facility Name
Dept of Dermatology
City
Copenhagen
ZIP/Postal Code
dk-2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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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Fast Track Diagnosis of Skin Cancer by Advanced Imaging

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