Clinical trial · Observational
Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
Multicenter Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Dermatology patients
- description
- Patients with a suspicious skin lesion indicated for biopsy
Primary outcomes (1)
- measure
- A comparison between gold standard histopathology screening results and mAID screening results
- timeFrame
- Day 1
- description
- 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.
Secondary outcomes (1)
- measure
- A comparison between gold standard histopathology screening results and analysis of the standard dermatoscope image.
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Participant has normal appearing skin and a suspicious pigmented lesion. Exclusion Criteria: * Lesion near the eyes (due to safety) * Inaccessibility to lesion related to device: ears, toes, fingers, nailbeds, ankles, elbows, genitals * Self-reported history of photosensitivity * Self-reported history of vitiligo and/or other sun sensitive disease
References
Publications (0)
Data not yet available