Clinical trial · Observational
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.
Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
NCT02009085CI-TRIAL-00031704completedClinicalTrials.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)
In this study a fluorescent contrast dye is applied to a suspicious skin lesion. Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation 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
- Individuals undergoing skin excision.
- description
- Skin lesions are under suspicion for skin cancer.
Primary outcomes (1)
- measure
- Correlation between imaging and pathology.
- timeFrame
- No long term follow up is necessary.
- description
- Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.
Secondary outcomes (1)
- measure
- Acute response
- timeFrame
- up to 1 day
- description
- The acute dermal response to the imaging procedure is evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over the age of 18 * Individual is scheduled for a skin biopsy in toto * The lesion is pigmented or non pigmented * Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis. * The lesion is accessible to the imaging device Exclusion Criteria: * The patient has sensitive skin and easily breaks out in rash * The lesion is within 1 cm of the eye * The lesion is on mucosal surfaces (e.g., lips, genitals) * Pregnant females * Taking medications that pigments the skin
References
Publications (0)
Data not yet available
No reference posted for this study.