Optical Coherence Microscopy in Dermato-oncology

Skin Cancer Clinical Trial

— OCTAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731247
• Other study ID #: 18CH071
• Secondary ID: 2018-A02012-53
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: April 21, 2021

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	DAMAE Médical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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