Clinical trial NCT03621462: Elucid Labs AIDA™ - Labelled Image Acquisition Protocol
Official title: Acquiring Images of Pigmented Skin Lesions With the Artificial Intelligence Dermatology Assistant (AIDA™) and Concurrent in Vivo Assessment for the Evaluation of Diagnostic Accuracy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma (Skin)
Basal Cell Carcinoma of the Skin
Squamous Cell Carcinoma of the Skin
Lead sponsor: Elucid Labs Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
timeFrame: Average of 4 weeks
measure: Specificity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
timeFrame: Average of 4 weeks
Secondary outcomes:
Other outcomes:
measure: Concordance of investigators' AIDA™-based lesion depth estimate to actual depth measurement on biopsy report
timeFrame: Average of 4 weeks
measure: Overall diagnostic accuracy (AUC of the ROC) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
timeFrame: Average of 4 weeks
measure: Positive and Negative predictive values (PPV and NPV) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
timeFrame: Average of 4 weeks
Locations:
city: Calgary
country: Canada
facility: Total Skincare Centre
state: Alberta
Study officials:
affiliation: Total Skincare Centre
name: John Arlette, MD
role: PRINCIPAL_INVESTIGATOR
References: