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

intraoperative characterization of head and neck tumors using confocal laser endomicroscopy during surgical treatment with systemic indocyanine green application - CLE HNSCC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025564

Enrollment

100

Registered

2021-06-15

Start date

2021-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C04 C05 C06 C10 C11 C12

Interventions

Group 1: benign and malignant head and neck tumors

during surgical procedures in general anesthesia for taking biopsies or tumor resection, CLE images are taken before and after resection/biopsy with and without systemic application of indocyanine gre

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactMaximilian Linxweiler

Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

maximilian.linxweiler@uks.eu+496841-1622984

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026