Carcinoma Clinical Trial
— OCTSKINOfficial title:
Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
Verified date | March 2019 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures
such as biopsy or excision in order to analyze the structure and appearance of the fabric
pathologists. With recent advances in optical and electronic fields, considerable efforts
were produced to build high-performance optical instruments, able to transcribe the internal
structure of the skin with varying degrees of depth and variable resolution.
The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and
in real time. This area is booming and new optical instruments are created to eventually be
able to offer a reliable alternative to invasive techniques.
The optical properties of different tissues have been studied for several years by different
research groups: the coefficient of light absorption by the tissue both in vivo and in vitro,
the coefficient of light scattering or the index refractive were characterized in various
tissues that make up the skin.
Other studies have focused on melanoma detection by multispectral optical techniques, or via
the technique of optical coherence tomography (OCT) performed on lesions suspicious for
cancer, but without linking criteria between these two techniques.
However, no study to date and to our knowledge has been able to demonstrate the different
optical parameters obtained with OCT and can be directly connected to known and
histopathological parameters commonly used in the diagnosis of lesions skin. This study aims
to verify if it is possible to determine the parameters measured in OCT that would
discriminate between benign and malignant lesions.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2017 |
Est. primary completion date | December 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision; - consent signed Exclusion Criteria: - Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements; - pregnant and nursing women - patients under tutorship or curatorship |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | National Research Agency, France |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite endpoint | thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence) | at baseline | |
Secondary | implementation duration | minutes | at baseline | |
Secondary | acquisition practices duration | minutes | at baseline | |
Secondary | the duration of analysis image | minutes | at baseline | |
Secondary | utility of labeling with a dye for histology to locate the lesion | yes or no | at baseline |
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