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Artificial Intelligence-assisted Evaluation of Pigmented Skin Lesions

NCT03362138 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-09-13

No results posted yet for this study

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

Interventions

DEVICE

dermoscopy

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.

Sponsors & Collaborators

  • Assuta Hospital Systems

    lead OTHER

Principal Investigators

  • Avi Dascalu, MD. Ph.D. · Bostel LLC

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362138 on ClinicalTrials.gov