Clinical trial · Interventional
Confocal Microscopy Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery
Does Ex-vivo Fluorescence Confocal Microscopy Allow Faster Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery: A Pilot Study
NCT03610620CI-TRIAL-00041966FCM-PcompletedN/AClinicalTrials.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)
This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery.
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 |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vivascope 2500 ex-vivo fluorescent confocal microscope | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- Vivascope 2500 ex-vivo fluorescent confocal microscope
- interventionNames
- Procedure: Vivascope 2500 ex-vivo fluorescent confocal microscope
Primary outcomes (1)
- measure
- To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
- timeFrame
- 1 DAY
- description
- Compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Secondary outcomes (1)
- measure
- To compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older 2. Patient with basal cell carcinoma on the head and neck undergoing Mohs surgery with frozen sections 3. Patient willing and able to give informed consent 4. Patient treated not previously or currently treated with a hedgehog inhibitor medication (vismodegib) 5. Patient suitable for Mohs surgery 6. Excised lesion suitable for scanning with FCM as determined by investigator - Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.