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

NCT05935995 | Active Not Recruiting

• 1 other identifier: 2023-A00818-37
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

margin surgical; confocal microscopy; conventional histopathology (H&E)

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard

  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).

  1 day

Study Arms (1)

Microscopy confocal

EXPERIMENTAL

Other: microscopy confocal (Histolog Scanner)

Interventions

microscopy confocal (Histolog Scanner) 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.

Microscopy confocal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Basal Cell; Margins of Excision

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Basal Cell; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GILLES DOLIVET, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: November 28, 2023
• Primary Completion: June 21, 2025
• Study Completion: March 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)