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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— HISTOBLOC  

Official title:

Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935995
• Other study ID #: 2023-A00818-37
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: JEAN LOUIS MERLIN, PharmD, PhD
• Phone: +33383656062
• Email: jl.merlin[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Gilles Dolivet	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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