NCT05935995

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-11-28
• Primary completion: 2025-06-21
• Completion: 2026-03-01
• First posted: 2023-07-07
• Last updated: 2025-11-28

Locations

1 site across 1 country: France