Clinical trial · Observational
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)
Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
NCT03535077CI-TRIAL-00072882completedClinicalTrials.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 goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Suspicious Nevi undergoing biopsy
- description
- Subject with suspicious Nevi undergoing biopsy per SOC
- interventionNames
- Other: Diagnostic Test
Primary outcomes (1)
- measure
- Correlation
- timeFrame
- 1 day
- description
- To identify histological features that correlate with the imaging features captured using SFI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with a pigmented skin lesion recommended for a skin biopsy. 2. A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS. 3. At least 21 years old. 4. Written, signed, and dated informed consent 5. Scheduled for a primary excision/biopsy as part of the clinics SOC. Exclusion Criteria: 1. Lesion is less than 1 centimeter from the eyes. 2. Lesion is on the palms of the hands or soles of the feet. 3. Mucosal lesion. 4. Ulcerated lesion. 5. Subject is pregnant or planning to become pregnant during the study period. 6. Patients who are mentally or physically unable to comply with all aspects of the study. 7. Any subject undergoing chemotherapy. 8. Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.
References
Publications (0)
Data not yet available
No reference posted for this study.