Improving Skin Cancer Management With Artificial Intelligence (04.17 SMARTI) (SMARTI)

August 12, 2021 updated by: Melanoma and Skin Cancer Trials Limited

A Pilot Study of an Artificial Intelligence System as a Diagnostic Aid to Improve Skin Cancer Management (04.17 SMARTI)

The study is designed to be able to prove if the Molemap Artificial Intelligence (AI) algorithm can be used as a diagnostic aid in a clinical setting. This study will determine whether the diagnostic accuracy of the Molemap AI algorithm is comparable to a specialist dermatologist, teledermatologist and registrar (as a surrogate for a general practitioner). The study patient population will be adult patients who require skin cancer assessment.

The use of AI as a diagnostic aid may assist primary care physicians who have variable skill in skin cancer diagnosis and lead to more appropriate referrals (rapid referral for lesions requiring treatment and fewer referrals for benign lesions), thereby improving access and reducing waiting times for specialist care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study which aims to establish whether artificial intelligence can be used as a diagnostic aid to improve diagnostic accuracy and outcomes in the specialist setting prior to conducting a much larger trial of the intervention in primary care.

Objectives:

  1. To establish whether the diagnostic accuracy of an artificial intelligence system is on par with teledermatologists' clinical assessment.
  2. To establish the safety and feasibility of offering artificial intelligence as a diagnostic aid prior to conducting a large trial of the intervention in primary care.

Hypotheses:

  1. The AI algorithm will have diagnostic accuracy comparable with a teledermatologists' assessment.
  2. The AI algorithm will have a diagnostic accuracy more conservative (i.e. more false positives) than dermatologists in the clinical setting.
  3. The AI algorithm will have greater diagnostic accuracy than the registrar.
  4. The AI algorithm will lead to a reduction in the number of biopsies performed by the registrar the likely impact of which will be reduced cost to patients and the healthcare system.

Trial Design:

The pilot study will take place in specialist dermatology and melanoma clinics in Victoria, Australia. Potential participants will be identified and screened at the general dermatology and melanoma clinics by the clinic doctors who deem the participant meet the inclusion and exclusion criteria.

Intervention:

Photography of lesions using a MoleMap camera device with automated artificial intelligence providing an assessment of the lesion in real time.

This pilot study will be a before and after intervention trial design. For the initial 'lead-in' phase, no AI diagnosis will be provided back to the treating clinicians. This phase will be used for prospective data collection.

For the intervention phase, an AI diagnosis will be provided to the dermatology registrar (who is used in this pilot study as a surrogate for the GP) and dermatologist after they have both assessed the patient clinically. Management of the lesion will be determined by the dermatologist and recorded.

The safety of the device will be determined by its use in the setting of specialist dermatology clinics to ensure that patients are receiving the highest standard of care with a dermatologist providing a clinical diagnosis and management for all lesions tested.

It is anticipated that the full trial will expand to include multiple sites across Australia and New Zealand.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred- Victorian Melanoma Service
      • Melbourne, Victoria, Australia, 3053
        • Skin Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients attending the specialist dermatology clinics for skin cancer assessment or surveillance.
  2. Patients may or may not have a lesion of concern.
  3. Patients must have at least two lesions imaged during full skin examination by a dermatologist.
  4. Age greater than 18 years.
  5. Participant is willing and able to undertake investigation of suspicious lesion (e.g. skin biopsy).

Exclusion Criteria:

  1. Patient does not give informed consent.
  2. Patient is unable or unwilling to have a full skin examination
  3. Patient has a known past or current diagnosis of cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Lead-in phase
During the lead-in phase treating clinicians will not be given the Molemap artificial intelligence diagnosis in real-time (i.e. in clinic with the patient).
Active Comparator: Active phase
During the active phase treating clinicians will be given the Molemap artificial intelligence diagnosis in real-time.
Device: Molemap Skin Cancer Triage Artificial Intelligence Device
This device/software incorporates artificial intelligence to provide a diagnostic aide for clinicians of patients with potentially malignant skin lesions. The software is supported by the use of cameras for acquisition of images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the device when compared prospectively to a teledermatologist assesment
Time Frame: 12 months
Sensitivity and specificity of the algorithm compared to the teledermatologist.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the device when used prospectively as compared to a dermatologist assessment
Time Frame: 12 months
Sensitivity and specificity of the algorithm compared to the dermatologist.
12 months
Diagnostic accuracy of the device compared to teledermatologist, dermatologist and registrar using histopathology as 'gold standard' for any lesions biopsied.
Time Frame: 12 months
Sensitivity and specificity of the algorithm compared to histopathology of any lesions biopsied.
12 months
Appropriate selection of lesions by registrar compared to specialist dermatologists
Time Frame: 12 months
This will be assessed by comparing the lesions selected for review by the registrar with the lesions selected by the dermatologist.
12 months
Appropriateness of management by registrar compared to specialist dermatologists and impact AI might have on this.
Time Frame: 12 months
This will be assessed by comparing the registrars clinical assessment with the dermatologists clinical assessment and if providing the AI assessment in real time has an impact.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melanoma and Skin Cancer Trials Limited

Collaborators

Monash University

Investigators

  • Study Chair: Victoria Mar, A/Prof, Monash University, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

May 19, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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