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Digital Labeling and Intraoperative Navigation in the Treatment of Head and Neck Tumors

Digital Labeling and Intraoperative Navigation in the Treatment of Head and Neck Tumors - CMF Navigation Labeling

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037433
Enrollment
13
Registered
2025-07-24
Start date
2025-10-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

C02 C03 C04 C05 C06

Interventions

Group 1: In this prospective clinical observational study, the use of perioperative MRI and CT imaging will be evaluated in patients with head and neck tumors undergoing primary surgical resection, re

Sponsors

Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Initial diagnosis of a head and neck tumor Availability of pretherapeutic staging procedures using CT and/or MRI of the neck Treatment recommendation for primary surgery by the interdisciplinary head and neck tumor board Planned tumor resection with accompanying cervical lymph node dissection

Exclusion criteria

Exclusion criteria: Recurrence of tumor Age under 18 years

Design outcomes

Primary

MeasureTime frame
Surgical duration – impact of digital marking and navigation on operative time

Secondary

MeasureTime frame
• R status of tumor resection (microscopic tumor clearance) – as the central oncological treatment goal • Sensitivity of resected lymph node samples regarding tumor positivity – i.e., the diagnostic accuracy of navigated lymph node sampling in detecting metastases • Preoperative planning time – effort required to generate the digital patient model and prepare the surgical procedure • Objectification of interdisciplinary communication – measured using standardized questionnaires among radiology, oral and maxillofacial surgery, pathology, radiation oncology, etc. • Feasibility in daily clinical practice – practical integration of digital navigation under routine conditions (questionnaires) • Improvement in the topographic localization of frozen sections and lymph node samples – compared to the purely anatomical-descriptive standard method (questionnaires)

Countries

Germany

Contacts

Public ContactPhilipp Thönißen

Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie

thoenissen@med.uni-frankfurt.de+496963013744

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026