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Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

NCT05935995 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-11-28

No results posted yet for this study

Summary

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

  • Squamous Cell Carcinoma of Head and Neck
  • Basal Cell Carcinoma of Skin

Interventions

OTHER

microscopy confocal (Histolog Scanner)

Surgical margins of tumor samples will be examined by conventional histopathology (H\&E) and confocal microscopy (Histolog® scanner, SamanTree Medical, Switzerland). Depending on the histopathological result obtained between the two methods, the patient may benefit directly from early surgery if the experimental result confirms the presence of positive margins (excluding the learning curve). A learning curve will be established over the first fifteen surgeries, enabling surgical teams to gain experience and systematize specimen flattening. This learning curve will also enable reference images to be produced. The procedure will be carried out by the surgeon and the pathologist in the operating room during this phase.

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • GILLES DOLIVET, MD · Institut de Cancérologie de Lorraine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2025-06-21
Completion
2026-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935995 on ClinicalTrials.gov