Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03621462
Other study ID # AIDA-PRO-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date October 15, 2020

Study information

Verified date August 2018
Source Elucid Labs Inc.
Contact Behnoud Kazemzadeh
Phone 647-467-0706
Email behnoud@elucidlabs.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to biopsy. Elucid Labs (Waterloo, Ontario) has developed a novel handheld, digital dermoscope with accompanying visualization and analysis software - the Artificial Intelligence Dermatology Assistant (AIDA™). Apart from collecting conventional demoscopic images, AIDA also collects images at various spectral bands. The aim of this study is to understand and quantify the value of this novel adjunctive information for dermatologists diagnosing atypical skin lesions.


Description:

Patients presenting with atypical skin lesions will undergo assessment by an investigator as per their standard clinical practice (not utilizing AIDA™). If a lesion meeting the inclusion-exclusion criteria is referred for biopsy, informed consent will be obtained and the subject will be enrolled. Subjects will then have images acquired by the AIDA™ system. All lesions scheduled for biopsy (Subgroup A) will be imaged along with at most 2 additional lesions meeting inclusion/exclusion criteria but not referred for biopsy (Subgroup B). For each lesion imaged using AIDA™, the investigator will manually segment the lesion image and list any lesion features which contributed to their recommendation to biopsy or not biopsy. The investigator will first score the lesion according to the ABCD rule using the standard dermoscopy image displayed. They will then state their diagnosis (malignant, dyplastic, or benign) and their diagnostic confidence using a visual analog scale. Once standard demoscopy diagnosis has been collected, the process will be repeated with the use of AIDA™ software outputs. Investigators will also provide an estimate of lesion depth based on AIDA™ depth images. All biopsy results will be recorded by the pathologist. Histopathology determination will be used as the definitive diagnosis of either positive (malignant/dysplastic) or negative (benign). Complete de-identified pathology reports may also be collected.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4000
Est. completion date October 15, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Is 18 years of age or older

2. Has provided informed consent to participate in the study

3. Is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following:

1. Has a diameter of at least 1 mm and at most 10 mm

2. Is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage)

3. Is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails

4. Is intact (eg. no open sores, ulcers, bleeding)

5. Has not previously been biopsied, excised or traumatized

6. Does not contain visible scarring or foreign material (eg. tattoos, etc.)

Exclusion Criteria:

1. Any allergy to isopropyl alcohol

Study Design


Intervention

Device:
Artificial Intelligence Dermatology Assistant (AIDA™)
The Artificial Intelligence Dermatology Assistant (AIDA™) collects conventional demoscopic images and images at various spectral bands. Following image acquisition, the AIDA™ software presents users with (1) similar lesion images from the International Skin Imaging Collaboration archive, (2) Hypodermoscopy™ images, and (3) images providing an indication of lesion depth, based on the spectral data.

Locations

Country Name City State
Canada Total Skincare Centre Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
Elucid Labs Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Concordance of investigators' AIDA™-based lesion depth estimate to actual depth measurement on biopsy report For all melanoma lesions biopsied in toto (completely excised), the lesion depth is stated within the histopathology report. As this cannot be established prior to biopsy, the investigator will estimate the depth of all lesions referred based on the AIDA™ software output. The concordance of that estimate will be compared to the actual depth stated in the histopathology reports for melanoma lesions biopsied in toto. Average of 4 weeks
Other Overall diagnostic accuracy (AUC of the ROC) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone Based on the sensitivity and specificity of dermatologists established when using AIDA™ output vs. standard dermoscopy and physical examination alone images, receiver operating characteristic (ROC) curves will be generated. The diagnostic accuracy, also known as the area under the curve (AUC) of the ROC will be calculated for each ROC curve and compared. Average of 4 weeks
Other Positive and Negative predictive values (PPV and NPV) of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone The predictive value of a diagnostic test is important in determining the applicability of the diagnostic technique. The positive predictive value (PPV) is determined by the equation TP/(TP + FP) and is the probability that a patient has the condition given a positive test result. The negative predictive value (NPV) is determined by the equation TN/(TN + FN) and is the probability that a patient does not have the condition given a negative test result.
The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The PPV and NPV of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports.
Average of 4 weeks
Primary Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The sensitivity of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports.
The sensitivity of a diagnostic technique determines the probability of a positive test result in a person who has the disease. This is defined according to the equation: TP/(TP + FN) . In this equation, TP is the number of true-positive and FN is the number of false-negative results.
Average of 4 weeks
Primary Specificity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The specificity of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports.
The specificity of a diagnostic technique refers to the probability of a negative test result in a person who does not have the disease according to the equation: TN/(TN + FP). In this equation, TN is the number of true-negative and FP is the number of false-positive results.
Average of 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT04062032 - Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma Phase 2
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Active, not recruiting NCT03291002 - Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC Phase 1
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Completed NCT00962845 - Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery Early Phase 1
Completed NCT00324623 - Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma Phase 1
Completed NCT00096382 - Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00104845 - Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 1
Completed NCT00072124 - Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma Phase 3
Completed NCT00089193 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 2
Completed NCT00072085 - Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma Phase 2
Active, not recruiting NCT00039234 - Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Phase 3
Completed NCT00049010 - Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma N/A
Completed NCT00042783 - Vaccine Therapy in Treating Patients With Stage IV Melanoma Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
Completed NCT00006385 - Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00005610 - Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Phase 2
Completed NCT00020358 - Vaccine Therapy in Treating Patients With Melanoma Phase 2
Recruiting NCT03767348 - Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1