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Trial Title:
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
NCT ID:
NCT05935995
Condition:
Squamous Cell Carcinoma of Head and Neck
Basal Cell Carcinoma of Skin
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
margin surgical
confocal microscopy
conventional histopathology (H&E)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
microscopy confocal (Histolog Scanner)
Description:
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 group label:
Microscopy confocal
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
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gilles Dolivet
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Recruiting
Contact:
Last name:
GILLES DOLIVET, MD
Phone:
+33383598446
Email:
g.dolivet@nancy.unicancer.fr
Start date:
November 28, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Institut de Cancérologie de Lorraine
Agency class:
Other
Source:
Institut de Cancérologie de Lorraine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05935995
