Melanoma (Skin)NCT03621462
Elucid Labs AIDA™ - Labelled Image Acquisition Protocol
A study testing Artificial Intelligence Dermatology Assistant (AIDA™) in people with Melanoma (Skin) and Basal Cell Carcinoma of the Skin, run by Elucid Labs Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Basal Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Skin
- What is being tested?
- Artificial Intelligence Dermatology Assistant (AIDA™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.)
Who cannot join
- 1. Any allergy to isopropyl alcohol
Trial locations and contacts
1 site in 1 country.
Canada1 site
Total Skincare Centre
Calgary, Alberta, T3C2G2
John Arlette, MD, 403-216-4685
About this study
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
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.
Read the 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.
- Being tested
- Artificial Intelligence Dermatology Assistant (AIDA™)
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Artificial Intelligence Dermatology Assistant (AIDA™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Oct 2018 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elucid Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Arlette, MD, Principal investigator, Total Skincare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621462
- Sponsor's protocol ID
- AIDA-PRO-001
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03621462
- Acronym / sponsor ID
- AIDA-PRO-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Elucid Labs Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquisition of Lesion Images with AIDA | Experimental | Device: Artificial Intelligence Dermatology Assistant (AIDA™)Subjects presenting with atypical skin lesions referred for biopsy will have their lesion imaged using the Artificial Intelligence Dermatology Assistant (AIDA™) study device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (1 listed)
- 1. Any allergy to isopropyl alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Acquisition of Lesion Images with AIDA |
Primary outcome
Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
Time frame: Average of 4 weeks
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.
Specificity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
Time frame: Average of 4 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Arlette, MD principal investigator
Total Skincare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Dermatology Assistant (AIDA™) in people with Melanoma (Skin) and Basal Cell Carcinoma of the Skin, run by Elucid Labs Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behnoud Kazemzadeh (647-467-0706, behnoud@elucidlabs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone (time frame: Average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.