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

NCT ID: NCT06271603

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 704 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Basal Cell Carcinoma of the Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device

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\'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.

Group Type: EXPERIMENTAL

diagnosis based on deepLive™ LC-OCT device

Intervention Type: DIAGNOSTIC_TEST

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

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

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.

Group Type: ACTIVE_COMPARATOR

diagnosis based on skin biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

diagnosis based on deepLive™ LC-OCT device

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

Intervention Type: DIAGNOSTIC_TEST

diagnosis based on skin biopsy

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

LC-OCT arm; biopsy arm

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damae Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Countries

France

Central Contacts

Philippe Saiag

Role: CONTACT

philippe.saiag@uvsq.fr

800-555-5555

Maxime Cazalas

Role: CONTACT

info@damae-medical.com

800-555-5555

Facility Contacts

Professeur Philippe SAIAG

Role: primary

philippe.saiag@uvsq.fr

800-555-5555

Other Identifiers

CPP Ile de France III

Identifier Type: OTHER

Identifier Source: secondary_id

23.02645.000357-MS01

Identifier Type: -

Identifier Source: org_study_id