Elucid Labs AIDA™ - Labelled Image Acquisition Protocol

NCT ID: NCT03621462

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-10-15

Brief Summary

Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to biopsy. Elucid Labs (Waterloo, Ontario) has developed a novel handheld, digital dermoscope with accompanying visualization and analysis software - the Artificial Intelligence Dermatology Assistant (AIDA™). Apart from collecting conventional demoscopic images, AIDA also collects images at various spectral bands. The aim of this study is to understand and quantify the value of this novel adjunctive information for dermatologists diagnosing atypical skin lesions.

Detailed Description

Patients presenting with atypical skin lesions will undergo assessment by an investigator as per their standard clinical practice (not utilizing AIDA™). If a lesion meeting the inclusion-exclusion criteria is referred for biopsy, informed consent will be obtained and the subject will be enrolled. Subjects will then have images acquired by the AIDA™ system. All lesions scheduled for biopsy (Subgroup A) will be imaged along with at most 2 additional lesions meeting inclusion/exclusion criteria but not referred for biopsy (Subgroup B). For each lesion imaged using AIDA™, the investigator will manually segment the lesion image and list any lesion features which contributed to their recommendation to biopsy or not biopsy. The investigator will first score the lesion according to the ABCD rule using the standard dermoscopy image displayed. They will then state their diagnosis (malignant, dyplastic, or benign) and their diagnostic confidence using a visual analog scale. Once standard demoscopy diagnosis has been collected, the process will be repeated with the use of AIDA™ software outputs. Investigators will also provide an estimate of lesion depth based on AIDA™ depth images. All biopsy results will be recorded by the pathologist. Histopathology determination will be used as the definitive diagnosis of either positive (malignant/dysplastic) or negative (benign). Complete de-identified pathology reports may also be collected.

Conditions

Melanoma (Skin); Basal Cell Carcinoma of the Skin; Squamous Cell Carcinoma of the Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Acquisition of Lesion Images with AIDA

Subjects presenting with atypical skin lesions referred for biopsy will have their lesion imaged using the Artificial Intelligence Dermatology Assistant (AIDA™) study device

Group Type: EXPERIMENTAL

Artificial Intelligence Dermatology Assistant (AIDA™)

Intervention Type: DEVICE

The Artificial Intelligence Dermatology Assistant (AIDA™) collects conventional demoscopic images and images at various spectral bands. Following image acquisition, the AIDA™ software presents users with (1) similar lesion images from the International Skin Imaging Collaboration archive, (2) Hypodermoscopy™ images, and (3) images providing an indication of lesion depth, based on the spectral data.

Interventions

Artificial Intelligence Dermatology Assistant (AIDA™)

The Artificial Intelligence Dermatology Assistant (AIDA™) collects conventional demoscopic images and images at various spectral bands. Following image acquisition, the AIDA™ software presents users with (1) similar lesion images from the International Skin Imaging Collaboration archive, (2) Hypodermoscopy™ images, and (3) images providing an indication of lesion depth, based on the spectral data.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is 18 years of age or older

2. Has provided informed consent to participate in the study

3. Is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following:

1. Has a diameter of at least 1 mm and at most 10 mm

2. Is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage)

3. Is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails

4. Is intact (eg. no open sores, ulcers, bleeding)

5. Has not previously been biopsied, excised or traumatized

6. Does not contain visible scarring or foreign material (eg. tattoos, etc.)

Exclusion Criteria

1. Any allergy to isopropyl alcohol

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

Sponsors

Elucid Labs Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Arlette, MD

Role: PRINCIPAL_INVESTIGATOR

Total Skincare Centre

Locations

Total Skincare Centre

Calgary, Alberta, Canada

Countries

Canada

Central Contacts

Behnoud Kazemzadeh

Role: CONTACT

behnoud@elucidlabs.ca

647-467-0706

Facility Contacts

John Arlette, MD

Role: primary

403-216-4685

Other Identifiers

AIDA-PRO-001

Identifier Type: -

Identifier Source: org_study_id