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

I

Institut de Cancérologie de Lorraine

Status

Active, not recruiting

Conditions

Basal Cell Carcinoma of Skin
Squamous Cell Carcinoma of Head and Neck

Treatments

Other: microscopy confocal (Histolog Scanner)

Study type

Interventional

Funder types

Other

Identifiers

NCT05935995
2023-A00818-37

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

Microscopy confocal
Experimental group
Treatment:
Other: microscopy confocal (Histolog Scanner)

Trial contacts and locations

1

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Central trial contact

JEAN LOUIS MERLIN, PharmD, PhD

Data sourced from clinicaltrials.gov

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