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The interventional procedure involves the management of BCC with an initial diagnosis based on the deepLive™ device. The imaging is performed by placing the probe tip in contact with the patient\&#39;s skin after applying an immersion oil (paraffin) to the imaging area. The examination lasts only a few minutes and is painless. An integrated dermoscopic targeting system allows the operator to ensure proper positioning of the probe on the lesion and to ensure that the entire lesion has been captured for an accurate diagnosis. The images are displayed in real-time during the examination and directly evaluated by the investigator, who has the option to save images/videos at their discretion. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up, and intermediate evaluations may also be performed with the deepLive™ device depending on the initial management of BCC.

The control procedure corresponds to standard management of BCC with an initial diagnosis based on skin biopsy (standard management arm). The biopsy will be performed according to the standard practice of each center, using a 2 to 6 mm punch or shave biopsy, with prior injection of a local anesthetic. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up.

Management of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT technology.

diagnosis based on deepLive™ LC-OCT device

Control Arm: Standard management with an initial diagnosis based on skin biopsy

diagnosis based on skin biopsy

Philippe Saiag

Maxime Cazalas

Professeur Philippe SAIAG

Philippe SAIAG

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 \&#34;equivocal\&#34; 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 \&#34;optical\&#34; 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.

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)

The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. The clinical non-inferiority will be assessed by the proportion of success which is defined as the absence of residual or recurrent cancerous or precancerous lesions after 1 year of primary BCC through diagnosis with LC-OCT, as compared to traditional management.

The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Organizational effectiveness will be evaluated by measuring the total time spent by dermatologists and pathologists (in hours) for managing primary BCC through diagnosis with LC-OCT, as compared to traditional management.

The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Economic superiority will be assessed by comparing the total cost of management (€) of primary BCC through diagnosis with LC-OCT to traditional management.

Quality of life will be assessed using the EQ-5D-5L questionnaire

Anxiety will be assessed using a visual analog scale (score 0 - 10)

Patient satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.

Performance will be evaluated based on the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and accuracy of LC-OCT for the diagnosis and subtyping of BCC in all patients operated on or biopsied in the LC-OCT arm, using histological diagnosis as the gold standard.

Physician satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.

Actual cost (€) of conducting the diagnosis with deepLive™ measured using micro-costing methodology

Typology of healthcare consumption at 1 year in each group to identify differences between the two groups in terms of: consultations, treatments, hospitalizations, medical procedures, laboratory tests, imaging, etc.

The descriptive cost-consequence analysis will analyze the difference in patient management costs at 1 year in relation to the impacts of deepLive™ on other clinical and organizational criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT06271603	Basal Cell Carc...	diagnosis based... diagnosis based...	18 Years -	Damae Medical
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	NCT06271603	Basal Cell Carc...	diagnosis based... diagnosis based...	18 Years -	Damae Medical

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