Clinical trial · Observational
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
NCT01556503CI-TRIAL-00021902completedClinicalTrials.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)
The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VivaScope System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pigmented Lesion
- description
- Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.
- interventionNames
- Device: VivaScope System
Primary outcomes (2)
- measure
- Sensitivity of confocal microscope to improve melanoma detection
- timeFrame
- Up to 1 year
- description
- Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.
- measure
- Specificity of the confocal microscope to improve melanoma detection
- timeFrame
- Up to 1 year
- description
- Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Age 12 or older * Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study * Signed informed consent Exclusion Criteria: * Age \< 12 years
References
Publications (0)
Data not yet available
No reference posted for this study.