Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas

Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas (ECOBASO)

This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.

Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain "equivocal" lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for "optical" biopsies, which appear as an attractive alternative to traditional biopsies.

The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.

Inclusion Criteria:

Patient with one or more clinically suspicious lesions of BCC for which:

1. The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
2. And/or for which the knowledge of the histological subtype determines the subsequent management.
3. And/or for which diagnostic biopsy is necessary in the standard practice to confirm the clinical diagnosis (peri-orificial facial lesions, any lesion that may require complex surgical reconstruction).

Exclusion Criteria:

• The lesion is suspected to be a recurrent BCC.
• The suspicious lesion has been previously treated by other surgical or non-surgical methods (cryotherapy, topical treatment, PDT, etc.).
• Lesions within 3 cm of the eye.
• Presence of cutaneous comorbidities that could interfere with a proper evaluation of the studied lesion according to the investigator.