Clinical trial · Interventional
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
NCT05935995CI-TRIAL-00124978HISTOBLOCcompletedN/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)
Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck
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 |
|---|---|---|---|
| Basal Cell Carcinoma of Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microscopy confocal (Histolog Scanner) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microscopy confocal
- interventionNames
- Other: microscopy confocal (Histolog Scanner)
Primary outcomes (1)
- measure
- Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard
- timeFrame
- 1 day
- description
- The concordance of intraoperative diagnosis between the two methods will be assessed by the condition of the margins of surgical specimens. Diagnostic accuracy will be measured by the sensitivity and specificity of confocal microscopy, using conventional histology reports from extemporaneous examination as the gold standard. * negative margins (absence of tumour cells) ; * positive margins (presence of tumour cells).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient ≥18 years old * Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin. * Patient whose surgical indication has been validated in a consultation meeting * Patients with scheduled surgery * WHO\< or =2 * ASA \< 3 * Patient affiliated to the social security system * Patient has understood, signed and dated the consent form. Exclusion Criteria: * History of irradiation in the surgical area * Women who are pregnant or who are breast-feeding. * Persons deprived of their liberty or under guardianship (including curators)
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Giacomo Gravante, Agnès Leroux, Christian Garbar et al. · JMIR Res Protoc · Sep 9, 2026 · PMID 42714336 pubmed