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Withdrawn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
About this trial
This is an interventional diagnostic trial for Mixed Tumor, Malignant
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
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
NCT ID
NCT02851693
First Posted
July 28, 2016
Last Updated
April 2, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
National Research Agency, France
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Withdrawn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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