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

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935995

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck Basal Cell Carcinoma of Skin	Other: microscopy confocal (Histolog Scanner)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microscopy confocal	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.

Arm

Intervention/Treatment

Experimental: Microscopy confocal

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 able and willing to follow all study procedures in accordance with the protocol.
Patient has understood, signed and dated the consent form.

Exclusion Criteria:

History of irradiation in the surgical area
Women who are pregnant, likely to become pregnant, or who are breast-feeding.
Persons deprived of their liberty or under guardianship (including curators)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gilles Dolivet	Vandœuvre-lès-Nancy		France	54500

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

Principal Investigator: GILLES DOLIVET, MD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de Cancérologie de Lorraine

ClinicalTrials.gov Identifier:

NCT05935995

Other Study ID Numbers:

2023-A00818-37

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut de Cancérologie de Lorraine

margin surgical

confocal microscopy

conventional histopathology (H&E)

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Basal Cell

Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Jul 10, 2023