First Optical Coherence Microscopy in Dermato-oncology (GALAXY)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Skin Cancer

Treatments: Device: OCTAV Patient; Device: OCTAV Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03079232

1608015

2016-A00319-42 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

OCTAV Patient

Experimental group

Description:

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)

Treatment:

Device: OCTAV Patient

OCTAV Control group

Experimental group

Description:

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

Treatment:

Device: OCTAV Control group