Clinical trial · Interventional
Melanoma Image Analysis Algorithm (MIAA) Validation Study
Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
NCT02612168CI-TRIAL-00036737completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melanoma Image Analysis Algorithm (MIAA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- Each patient will have any pigmented lesions (PLs) which are due to be biopsied, two PLs not due for biopsy and one patch of healthy skin photographed. Each will be photographed using three cameras: A standard DSLR and two smartphones with a dermoscopic lens attachment. Photographic images will be analysed by Melanoma Image Analysis Algorithm (MIAA)
- interventionNames
- Device: Melanoma Image Analysis Algorithm (MIAA)
Primary outcomes (1)
- measure
- The Area Under the Curve of a Receiver Operating Characteristic (AUROC) curve of MIAA result, using a maximum likelihood estimation (MLE) from all of the available images of biopsied lesions, compared to the biopsy result
- timeFrame
- Study completion, on average 2 weeks
- description
- Compare the MIAA result with the biopsy result
Secondary outcomes (31)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study, * Male or Female, aged 18 years or above, * Have at least 1 lesion suitable for photographing that is scheduled for biopsy to determine the presence of melanoma, * In the Investigators opinion, able and willing to comply with all study requirements. Exclusion Criteria: • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.