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OCTAV: Optical Coherence Microscopy in Dermato-oncology

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT03731247
Collaborator
DAMAE Médical (Other)
273
Enrollment
1
Location
2
Arms
30.1
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Condition or Disease Intervention/Treatment Phase
  • Device: OCTAV Patient
  • Device: OCTAV Control group
 N/A

Detailed Description

At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Study Design

Study Type:
Interventional
Actual Enrollment :
273 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One group of skin cancer patients One group without skin cancer patientsOne group of skin cancer patients One group without skin cancer patients
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Actual Study Start Date :
Oct 19, 2018
Actual Primary Completion Date :
Apr 21, 2021
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: OCTAV Patient

The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Device: OCTAV Patient
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Other Names:
  • OCTAV, DAMAE Medical, Paris, France

    		•
    Experimental: OCTAV Control group

    Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

    Device: OCTAV Control group
    In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
    Other Names:
  • OCTAV, DAMAE Medical, Paris, France

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity [Day 1]

      Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

    2. Specificity [Day 1]

      Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

    Secondary Outcome Measures

    1. Measure of the thickness of the different skin layers (mm) [Day 1]

      Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    FOR PATIENT

    Inclusion Criteria:

    • Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision

    • Consent form signed

    • Major patient

    Exclusion Criteria:

    • Allergy or intolerance to immersion oil (used for microscopy)

    • If female, pregnant or breast-feeding

    • Patient unable to stand still for 60 seconds

    • Skin lesions located near patient eyes (<3 cm)

    FOR CONTROL GROUP

    Inclusion Criteria:

    • Aged between 18 to 40 years

    • Consent form signed

    • Patient of the dermatology department with non-pathological forearm skin

    Exclusion Criteria:

    • Allergy or intolerance to immersion oil (used for microscopy)

    • If female, pregnant or breast-feeding

    • Patient unable to stand still for 60 seconds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu de Saint Etienne Saint Etienne France 42000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne
    • DAMAE Médical

    Investigators

    • Principal Investigator: Jean-Luc PERROT, MD, CHU SAINT ETIENNE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT03731247
    Other Study ID Numbers:
    • 18CH071
    • 2018-A02012-53
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    Optical biopsy
    Skin cancer
    Diagnostic performance
    Additional relevant MeSH terms:
    Skin Neoplasms

    Study Results

    No Results Posted as of Dec 7, 2021