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

NCT ID: NCT05935995

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Microscopy confocal

Group Type: EXPERIMENTAL

microscopy confocal (Histolog Scanner)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GILLES DOLIVET, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2023-A00818-37

Identifier Type: -

Identifier Source: org_study_id