First Optical Coherence Microscopy in Dermato-oncology (GALAXY)

In Vivo Imaging Innovation : 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).

Study Overview

• Status: Completed
• Conditions: Skin Cancer
• Intervention / Treatment: Device: OCTAV Patient; Device: OCTAV Control group

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42000
    • CHU de Saint Étienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)	Day 1
Specificity	Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the thickness of the different skin layers (mm)	Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: DAMAE Médical
• Investigators: Principal Investigator: Jean-Luc PERROT, MD, CHU Saint Etienne; Study Chair: Cécile DUPONT, PhD, Damae Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Skin cancer; Diagnostic performance; Optical biopsy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin Neoplasms
• Other Study ID Numbers: 1608015; 2016-A00319-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No