Artificial Intelligence-assisted Evaluation of Pigmented Skin Lesions

NCT03362138 | Unknown

• 1 other identifier: AQ16842
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year and 48000 deaths at a 1:28 lifetime incidence (2016). The golden standard, dermoscopy, enables Dermatologists to diagnose with a sensitivity of 40%, and a 8-12% specificity, approximately. Additional diagnostic abilities are restricted to devices which are either unproved or experimental. A new technology of Neuronal Network Clinical Decision Support (NNCD) was developed. It uses a dermoscopic imaging device and a camera able to capture an image. The photo is transferred to a Cloud Server and further analyzed by a trained classifier. Classifier training is aimed at a high accuracy diagnosis of Dysplastic Nevi (DN), Spitz Nevi and Malignant Melanoma detection with assistance from a Deep Neuronal Learning network (DLN). Diagnosis output is an excise or do not excise recommendation for pigmented skin lesions. A total of 80 subjects already referred to biopsy pigmented skin lesions will be examined by dermoscopy imaging in a non interventional study. Artificial Intelligence output results, as measured by 2 different dermoscopes, to be compared to ground truth biopsies, by either classifier decisions or a novel Modified Classifier Technology output decisions. Primary endpoints are sensitivity and specificity detection of the NNCD techniques. Secondary endpoints are the positive and negative prediction ratios of NNCD techniques.

Conditions

Melanoma; Pigmented Skin Lesion; Dysplastic Nevi

Keywords

melanoma; dysplastic nevus; artificial intelligence; early diagnosis

Outcome Measures

Primary Outcomes (2)

• Sensitivity for Classifier results as compared to biopsy

  A Sensitivity of at least 75% for Classifier results as compared to biopsy

  15 months

• Sensitivity for MCT results as compared to biopsy

  A Sensitivity of at least 85% for Classifier results as compared to biopsy

  15 months

Secondary Outcomes (2)

• The positive predictive value of MCT

  15 months

• The negative predictive value of MCT

  15 months

Study Arms (1)

Dermoscopy

Dermoscopic imaging of a lesion decided to be biopsied

Device: dermoscopy

Interventions

dermoscopy DEVICE

Solely after the dermatologist has decided to biopsy a lesion and sent the patient to biopsy, a dermoscopic image is captured by a camera attached to a dermoscope.

Dermoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects examined at a Dermatologic speciality clinic.

You may qualify if:

• Patient aged 18-90 years
• A pigmented lesion by dermoscopy.
• Clinical management by the examining dermatologist results in biopsy
• The diameter of the pigmented area is between 1 and 40 millimeters
• The patient has consented to participate in the study and has signed the Informed Consent Form

You may not qualify if:

• Non intact skin (ulcers, bleeding)
• The lesion is located within 1 cm of the eye
• The lesion is located on mucosal surfaces
• The lesion is on or under nails

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Maccabi Healthcare Clinic

Tel Aviv, 59485, Israel

RECRUITING

Related Publications (8)

• Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19.

  PMID: 24054424 BACKGROUND

• Mayer JE, Swetter SM, Fu T, Geller AC. Screening, early detection, education, and trends for melanoma: current status (2007-2013) and future directions: Part I. Epidemiology, high-risk groups, clinical strategies, and diagnostic technology. J Am Acad Dermatol. 2014 Oct;71(4):599.e1-599.e12; quiz 610, 599.e12. doi: 10.1016/j.jaad.2014.05.046.

  PMID: 25219716 BACKGROUND

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

  PMID: 22237781 BACKGROUND

• Noor O 2nd, Nanda A, Rao BK. A dermoscopy survey to assess who is using it and why it is or is not being used. Int J Dermatol. 2009 Sep;48(9):951-2. doi: 10.1111/j.1365-4632.2009.04095.x.

  PMID: 19702978 BACKGROUND

• American Academy of Dermatology Ad Hoc Task Force for the ABCDEs of Melanoma; Tsao H, Olazagasti JM, Cordoro KM, Brewer JD, Taylor SC, Bordeaux JS, Chren MM, Sober AJ, Tegeler C, Bhushan R, Begolka WS. Early detection of melanoma: reviewing the ABCDEs. J Am Acad Dermatol. 2015 Apr;72(4):717-23. doi: 10.1016/j.jaad.2015.01.025. Epub 2015 Feb 16.

  PMID: 25698455 BACKGROUND

• Campos-do-Carmo G, Ramos-e-Silva M. Dermoscopy: basic concepts. Int J Dermatol. 2008 Jul;47(7):712-9. doi: 10.1111/j.1365-4632.2008.03556.x.

  PMID: 18613881 BACKGROUND

• Dascalu A, David EO. Skin cancer detection by deep learning and sound analysis algorithms: A prospective clinical study of an elementary dermoscope. EBioMedicine. 2019 May;43:107-113. doi: 10.1016/j.ebiom.2019.04.055. Epub 2019 May 14.

  PMID: 31101596 DERIVED

• Walker BN, Rehg JM, Kalra A, Winters RM, Drews P, Dascalu J, David EO, Dascalu A. Dermoscopy diagnosis of cancerous lesions utilizing dual deep learning algorithms via visual and audio (sonification) outputs: Laboratory and prospective observational studies. EBioMedicine. 2019 Feb;40:176-183. doi: 10.1016/j.ebiom.2019.01.028. Epub 2019 Jan 20.

  PMID: 30674442 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsied lesion

MeSH Terms

Conditions

Melanoma; Dysplastic Nevus Syndrome; Disease

Interventions

Dermoscopy

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; Nevus; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Avi Dascalu, MD. Ph.D.

  Bostel LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avi Dascalu, MD, Ph.D.

CONTACT

+972544306331; dasc17@gmail.com

Robert Raleigh, MBA

CONTACT

+781-348-0707; rraleigh@braintreelabs.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 5, 2017
• Study Start: December 6, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: September 13, 2018

Record last verified: 2017-11

Locations

IL (1)