Artificial Intelligence-assisted Evaluation of Pigmented Skin Lesions (NNCD)
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|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
Dermoscopic imaging of a lesion decided to be biopsied
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.
- 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
- 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
- The positive predictive value of MCT [ Time Frame: 15 months ]The positive predictive value of MCT, compared to the biopsy result
- 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
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): NCT03362138
|Contact: Avi Dascalu, MD, Ph.D.||+email@example.com|
|Contact: Robert Raleigh, MBAfirstname.lastname@example.org|
|Maccabi Healthcare Clinic||Recruiting|
|Tel Aviv, Israel, 59485|
|Contact: Avi Dascalu, MD 97236099005 email@example.com|
|Principal Investigator:||Avi Dascalu, MD. Ph.D.||Bostel LLC|