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NCT02470273 · ClinicalTrials.gov registry record
Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
A clinical trial, sponsored by Rockefeller University.
- Completed
- Registry status
- 143
- Enrollment target
NCT02470273: Completed study, sponsored by Rockefeller University.
NCT02470273 is a clinical trial that has completed, run by Rockefeller University. The registered enrollment target is 143 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02470273 has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
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.
Primary Outcome
A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the mAID-produced hyperspectral image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2015-08-01 |
| Est. Completion | 2021-05-11 |
What the finished NCT02470273 record still lists
NCT02470273 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02470273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02470273 about?
NCT02470273 is a clinical study titled "Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)". 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 exter...
What is the current status of trial NCT02470273?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2015-08-01. Estimated completion is 2021-05-11.
Who is sponsoring clinical trial NCT02470273?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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