Clinical trial · Observational
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
NCT02056522CI-TRIAL-00048340completedClinicalTrials.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 use of MDS to access the presence of melanoma in the skin.
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 |
|---|---|---|---|
| Skin Lesions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Suspicious skin lesions.
- description
- No intervention is administered.
Primary outcomes (1)
- measure
- To validate the performance of MDS
- timeFrame
- 28 days
Secondary outcomes (1)
- measure
- To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 97 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy. * The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS. * Male and female ≥ 21 years old. * Subject is capable of giving written informed consent. * Primary excision. Exclusion Criteria: * The lesion is less than 1 cm from the eyes. * The lesion is on the palms of hands or soles of the feet. * Mucosal lesion. * Pregnant females. * Low study procedure compliance. * Patients who are mentally or physically unable to comply with all aspects of the study. * Undergoing chemotherapy. * Minor or legally incompetent and not able to sign the consent form. * Patient previously tested by MDS and was diagnosed with melanoma during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.