Clinical trial · Observational
Optical Imaging for Preoperative Delineation of Nonmelanoma Skin Cancers
Polarization Enhanced Wide Field Optical Imaging for Preoperative Delineation of Nonmelanoma Skin Cancers
- 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 the study is to evaluate the ability and efficacy of using a polarization-enhanced reflectance and fluorescence imaging device, PERFIS, (see the Device Brochure) for demarcation of nonmelanoma skin cancer margins prior to surgery. PERFIS is a harmless and non-invasive device that has been used to image biological tissue both in vitro and in vivo. In this study it will be used to image nonmelanoma skin cancer lesions prior to surgery. The use of PERFIS will not affect patient care or treatment decisions in any way. No extra tissue will be used for imaging.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polarization Enhanced Reflectance and Fluorescence System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Success or Failure of PERFIS in guiding pre-surgical marking
- timeFrame
- 1 hour
- description
- Success of PERFIS: If tumor margins are clear, and the PERFIS image indicates that collagen distortion lies within the pre-surgical marking of the surgeon, this would indicate that PERFIS could be useful in guiding pre-surgical marking. OR If tumor margins are positive, and PERFIS images detect collagen distortion in the area of tumor positivity such that the surgeon's pre-surgical marking would be altered to include more inconspicuous tumor, then the PERFIS analysis will be graded as successful. Failure of PERFIS: If tumor margins are clear, and the PERFIS image indicates the presence of collagen distortion beyond the surgeon's original marking, this would indicate failure of PERFIS to provide utility in guiding pre-surgical marking. OR If areas of the PERFIS image show distortion in both normal margins and in areas with histologically-proven tumor, then PERFIS will be graded as a failure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects, aged 18 and older, of any race or skin type * At least one biopsy-proven nonmelanoma skin cancer, scheduled to be treated by Mohs micrographic surgery Exclusion Criteria: * Pregnant women * Patients with tumors within 1 cm of the eye * Patients with tumors larger than 2 cm in diameter
References
Publications (4)
- BACKGROUNDSalasche SJ, Amonette RA. Morpheaform basal-cell epitheliomas. A study of subclinical extensions in a series of 51 cases. J Dermatol Surg Oncol. 1981 May;7(5):387-94. doi: 10.1111/j.1524-4725.1981.tb00662.x. No abstract available. PMID 7240543
- BACKGROUNDWolf DJ, Zitelli JA. Surgical margins for basal cell carcinoma. Arch Dermatol. 1987 Mar;123(3):340-4. PMID 3813602
- BACKGROUNDFeng X, Patel R, Yaroslavsky AN. Wavelength optimized cross-polarized wide-field imaging for noninvasive and rapid evaluation of dermal structures. J Biophotonics. 2015 Apr;8(4):324-31. doi: 10.1002/jbio.201400105. Epub 2015 Jan 19. PMID 25601353
- BACKGROUNDFeng X, Doherty S, Yaroslavsky I, Altshuler G, Yaroslavsky AN. Polarization enhanced wide-field imaging for evaluating dermal changes caused by non-ablative fractional laser treatment. Lasers Surg Med. 2016 Feb;48(2):150-6. doi: 10.1002/lsm.22390. Epub 2015 Aug 25. PMID 26304187