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Artificial Intelligence-assisted Evaluation of Pigmented Skin Lesions (NNCD)

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. Identifier: NCT03362138
Recruitment Status : Unknown
Verified November 2017 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
First Posted : December 5, 2017
Last Update Posted : September 13, 2018
Information provided by (Responsible Party):
Assuta Hospital Systems

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.

Condition or disease Intervention/treatment
Melanoma Pigmented Skin Lesion Dysplastic Nevi Device: dermoscopy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Dermoscopy Evaluation of Pigmented Skin Lesions by a Neuronal Network Clinical Decision Support: an Open Prospective Non Interventional Study
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Group/Cohort Intervention/treatment
Dermoscopic imaging of a lesion decided to be biopsied
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.

Primary Outcome Measures :
  1. Sensitivity for Classifier results as compared to biopsy [ Time Frame: 15 months ]
    A Sensitivity of at least 75% for Classifier results as compared to biopsy

  2. Sensitivity for MCT results as compared to biopsy [ Time Frame: 15 months ]
    A Sensitivity of at least 85% for Classifier results as compared to biopsy

Secondary Outcome Measures :
  1. The positive predictive value of MCT [ Time Frame: 15 months ]
    The positive predictive value of MCT, compared to the biopsy result

  2. The negative predictive value of MCT [ Time Frame: 15 months ]
    The negative predictive value of MCT, compared to the biopsy result

Biospecimen Retention:   Samples Without DNA
Biopsied lesion

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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects examined at a Dermatologic speciality clinic.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT03362138

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Contact: Avi Dascalu, MD, Ph.D. +972544306331
Contact: Robert Raleigh, MBA +781-348-0707

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Maccabi Healthcare Clinic Recruiting
Tel Aviv, Israel, 59485
Contact: Avi Dascalu, MD    97236099005   
Sponsors and Collaborators
Assuta Hospital Systems
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Principal Investigator: Avi Dascalu, MD. Ph.D. Bostel LLC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assuta Hospital Systems Identifier: NCT03362138    
Other Study ID Numbers: AQ16842
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: November 2017

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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.: Yes
Keywords provided by Assuta Hospital Systems:
dysplastic nevus
artificial intelligence
early diagnosis
Additional relevant MeSH terms:
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Dysplastic Nevus Syndrome
Pigmentation Disorders
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Diseases
Pathologic Processes
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn