Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04229277 |
Other study ID # |
H-19036900 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 9, 2019 |
Est. completion date |
June 1, 2021 |
Study information
Verified date |
June 2024 |
Source |
University Hospital Bispebjerg and Frederiksberg |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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.