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

Not Applicable

Recruiting

• Conditions: Basal Cell Carcinoma of Skin; Squamous Cell Carcinoma of Head and Neck
• Interventions: Other: microscopy confocal (Histolog Scanner)

• Registration Number: NCT05935995
• Lead Sponsor: Institut de Cancérologie de Lorraine

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-07
• Status Verified: 2023-11
• Study Start: 2023-11-28
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microscopy confocal	microscopy confocal (Histolog Scanner)	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard	1 day	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).

Trial Locations

Locations (1)

Gilles Dolivet; 🇫🇷 Vandœuvre-lès-Nancy, France