Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04040114
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : August 19, 2021
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
Melanoma and Skin Cancer Trials Limited

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Skin Cancer Melanoma (Skin) Device: Molemap Skin Cancer Triage Artificial Intelligence Device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Controlled before-and-after intervention study
Masking: Single (Outcomes Assessor)
Masking Description: Teledermatologist will be blinded to the Artificial Intelligence algorithm diagnosis.
Primary Purpose: Diagnostic
Official Title: A Pilot Study of an Artificial Intelligence System as a Diagnostic Aid to Improve Skin Cancer Management (04.17 SMARTI)
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040114


Locations
Layout table for location information
Australia, Victoria
The Alfred- Victorian Melanoma Service
Melbourne, Victoria, Australia, 3004
Skin Health Institute
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
Melanoma and Skin Cancer Trials Limited
Monash University
Investigators
Layout table for investigator information
Study Chair: Victoria Mar, A/Prof Monash University, Australia
Layout table for additonal information
Responsible Party: Melanoma and Skin Cancer Trials Limited
ClinicalTrials.gov Identifier: NCT04040114    
Other Study ID Numbers: 04.17
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Melanoma and Skin Cancer Trials Limited:
Artificial Intelligence
Surveillance
Melanoma
Skin Cancer
photography
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases