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Trial Title:
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
Condition:
Basal Cell Carcinoma of the Skin
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Conditions: Keywords:
basal cell carcinoma diagnosis
LC-OCT
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
diagnosis based on deepLive™ LC-OCT device
Description:
Management of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT
technology.
Arm group label:
Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device
Other name:
LC-OCT arm
Intervention type:
Diagnostic Test
Intervention name:
diagnosis based on skin biopsy
Description:
Control Arm: Standard management with an initial diagnosis based on skin biopsy
Arm group label:
Control Arm: Standard management with an initial diagnosis based on skin biopsy
Other name:
biopsy arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Ambroise Paré
Address:
City:
Boulogne-Billancourt
Zip:
92100
Country:
France
Contact:
Last name:
Professeur Philippe SAIAG
Phone:
800-555-5555
Email:
philippe.saiag@uvsq.fr
Investigator:
Last name:
Philippe SAIAG
Email:
Principal Investigator
Start date:
February 26, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Damae Medical
Agency class:
Industry
Source:
Damae Medical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06271603
