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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: HISTOBLOC

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2027
First posted: Jul 7, 2023
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting