Clinical trial · Interventional
First Optical Coherence Microscopy in Dermato-oncology
In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
NCT03079232CI-TRIAL-00085670GALAXYcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OCTAV Control group | Device | — | UNRESOLVED |
| OCTAV Patient | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OCTAV Patient
- 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)
- interventionNames
- Device: OCTAV Patient
- type
- EXPERIMENTAL
- label
- OCTAV Control group
- description
- Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
- interventionNames
- Device: OCTAV Control group
Primary outcomes (2)
- measure
- Sensitivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.