In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 273
- Locations
- 1
- Primary Endpoint
- Sensitivity
Study Overview
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).
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
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
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)
Intervention: OCTAV Patient (Device)
OCTAV Control group
Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
Intervention: OCTAV Control group (Device)
Outcomes
Primary Outcomes
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)
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
- Measure of the thickness of the different skin layers (mm)(Day 1)