Elucid Labs AIDA™ - Labelled Image Acquisition Protocol

NCT03621462 | Unknown

• 1 other identifier: AIDA-PRO-001
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone

  The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The sensitivity of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports. The sensitivity of a diagnostic technique determines the probability of a positive test result in a person who has the disease. This is defined according to the equation: TP/(TP + FN) . In this equation, TP is the number of true-positive and FN is the number of false-negative results.

  Average of 4 weeks

• Specificity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone

  The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The specificity of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports. The specificity of a diagnostic technique refers to the probability of a negative test result in a person who does not have the disease according to the equation: TN/(TN + FP). In this equation, TN is the number of true-negative and FP is the number of false-positive results.

  Average of 4 weeks

Other Outcomes (3)

• Concordance of investigators' AIDA™-based lesion depth estimate to actual depth measurement on biopsy report

  Average of 4 weeks

• Overall diagnostic accuracy (AUC of the ROC) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone

  Average of 4 weeks

• Positive and Negative predictive values (PPV and NPV) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone

  Average of 4 weeks

Study Arms (1)

Acquisition of Lesion Images with AIDA

EXPERIMENTAL

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

Device: Artificial Intelligence Dermatology Assistant (AIDA™)

Interventions

Artificial Intelligence Dermatology Assistant (AIDA™) 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.

Acquisition of Lesion Images with AIDA

Eligibility Criteria

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

You may qualify if:

• Is 18 years of age or older
• Has provided informed consent to participate in the study
• Is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following:
• Has a diameter of at least 1 mm and at most 10 mm
• Is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage)
• Is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails
• Is intact (eg. no open sores, ulcers, bleeding)
• Has not previously been biopsied, excised or traumatized
• Does not contain visible scarring or foreign material (eg. tattoos, etc.)

You may not qualify if:

• \. Any allergy to isopropyl alcohol

Sponsors & Collaborators

• Elucid Labs Inc.: lead

Study Sites (1)

Total Skincare Centre

Calgary, Alberta, T3C2G2, Canada

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell

Study Officials

• John Arlette, MD

  Total Skincare Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Behnoud Kazemzadeh

CONTACT

647-467-0706; behnoud@elucidlabs.ca

Study Design

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

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 8, 2018
• Study Start: October 15, 2018
• Primary Completion: September 1, 2020
• Study Completion: October 15, 2020
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)