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Completed

NCT Number: NCT03079232

First Optical Coherence Microscopy in Dermato-oncology

OCTAV is a medical device class I, not 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).

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint Etienne

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCTAV Patient

Device

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

OCTAV Control group

Device

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

Primary outcomes

  1. Sensitivity

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • DAMAE Médical

Registry information

Official study title

In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

Acronym: GALAXY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2017
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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