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Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection (OCTSKIN)

Primary Purpose

Mixed Tumor, Malignant, Biopsy, Resection

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optical Coherence Tomography (OCT) with Vivosight
Optical Coherence Tomography (OCT) with Skintell
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mixed Tumor, Malignant

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Optical Coherence Tomography (OCT)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    implementation duration
    minutes
    acquisition practices duration
    minutes
    the duration of analysis image
    minutes
    utility of labeling with a dye for histology to locate the lesion
    yes or no

    Full Information

    First Posted
    July 28, 2016
    Last Updated
    April 2, 2019
    Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
    Collaborators
    National Research Agency, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02851693
    Brief Title
    Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
    Acronym
    OCTSKIN
    Official Title
    Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No open study.
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    December 1, 2017 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
    Collaborators
    National Research Agency, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mixed Tumor, Malignant, Biopsy, Resection, Carcinoma, Keratosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Optical Coherence Tomography (OCT)
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Optical Coherence Tomography (OCT) with Vivosight
    Other Intervention Name(s)
    VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK)
    Intervention Description
    OCT used is Vivosight for diagnosis
    Intervention Type
    Device
    Intervention Name(s)
    Optical Coherence Tomography (OCT) with Skintell
    Other Intervention Name(s)
    SKINTELL (Agfa HealthCare, Heverlee, Belgium)
    Intervention Description
    OCT used is Skintell for diagnosis
    Primary Outcome Measure Information:
    Title
    composite endpoint
    Description
    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)
    Time Frame
    at baseline
    Secondary Outcome Measure Information:
    Title
    implementation duration
    Description
    minutes
    Time Frame
    at baseline
    Title
    acquisition practices duration
    Description
    minutes
    Time Frame
    at baseline
    Title
    the duration of analysis image
    Description
    minutes
    Time Frame
    at baseline
    Title
    utility of labeling with a dye for histology to locate the lesion
    Description
    yes or no
    Time Frame
    at baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Luc PERROT, MD
    Organizational Affiliation
    Centre Hospitalier Universitaire de Saint Etienne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

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