intraoperative characterization of head and neck tumors using confocal laser endomicroscopy during surgical treatment with systemic indocyanine green applicatio

Not Applicable

• Conditions: C04; C05; C06; C10; C11; C12; Malignant neoplasm of floor of mouth; Malignant neoplasm of palate; Malignant neoplasm of other and unspecified parts of mouth; Malignant neoplasm of oropharynx

• Registration Number: DRKS00025564
• Lead Sponsor: niversitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

indication for surgical treatment of head and neck tumors, age of 18 or older, legal capacity, no indocyanine green allergy

Exclusion Criteria

lack of medical indication for surgical treatment, age < 18 years, lacking legal capacity, indocyanine green allergy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of CLE imaging with H&E-staining of FFPE-tissue sections; CLE images as well as H&E stainings are evaluated by an pathologist as well as an ENT surgeon and they have to submit a final diagnosis. Evaluation of CLE images as well as H&E stainings will be completed within 7 days after the surgical procedure. Finally, discordance resp. concordance between CLE- and histology-based diagnoses will be analyzed.