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Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)

NCT02470273 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2023-05-24

No results posted yet for this study

Summary

The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.

Conditions

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • Skin and Cancer Associates

    collaborator UNKNOWN

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Daniel Gareau, PhD, MCR · Rockefeller University

Eligibility

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

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2021-05-11
Completion
2021-05-11

Countries

  • United States

Study Locations

More Related Trials

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 NCT02470273 on ClinicalTrials.gov