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 | Not Yet Recruiting

• 2 other identifiers: 23.02645.000357-MS01CPP Ile de France III
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma of the Skin

Keywords

basal cell carcinoma diagnosis; LC-OCT

Outcome Measures

Primary Outcomes (3)

• The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.

  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.

  from enrollment to the 1 year follow up

• The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT 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.

  from enrollment to the 1 year follow up

• The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT 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.

  from enrollment to the 1 year follow up

Secondary Outcomes (8)

• Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm.

  from enrollment to the 1 year follow up

• Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm.

  from enrollment to the 1 year follow up

• Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm.

  from enrollment to the 1 year follow up

• Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm.

  from enrollment to the 1 year follow up

• Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm

  from enrollment to the 1 year follow up

Study Arms (2)

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

EXPERIMENTAL

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.

Diagnostic Test: diagnosis based on deepLive™ LC-OCT device

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

ACTIVE COMPARATOR

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.

Diagnostic Test: diagnosis based on skin biopsy

Interventions

diagnosis based on deepLive™ LC-OCT device DIAGNOSTIC_TEST

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

Also known as: LC-OCT arm

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

diagnosis based on skin biopsy DIAGNOSTIC_TEST

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

Also known as: biopsy arm

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with one or more clinically suspicious lesions of BCC for which:
• The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
• And/or for which the knowledge of the histological subtype determines the subsequent management.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damae Medical: lead

Study Sites (1)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Central Study Contacts

Philippe Saiag

CONTACT

800-555-5555; philippe.saiag@uvsq.fr

Maxime Cazalas

CONTACT

800-555-5555; info@damae-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 22, 2024
• Study Start: February 26, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (1)