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RECRUITING
NCT07548268
NA

Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

Sponsor: Tobias Todsen

View on ClinicalTrials.gov

Summary

Introduction The current diagnostic approach for patients with suspected oropharyngeal cancer involves a combination of clinical examination, tissue sampling, and relevant cross-sectional imaging. Previous studies have shown that transoral and cervical ultrasound (US) of the palatine and lingual tonsils has a better diagnostic accuracy than clinical investigation and magnetic resonance imaging (MRI) in patients with suspected oropharyngeal cancer, but it has not been established whether adding this scan to the diagnostic workup has a clinical impact. Methods A randomized controlled study, including 170 patients at four different Head and Neck Hospital departments in Denmark. One group receives standard diagnostics (control group), and the other group receives standard diagnostics supplemented by transoral and cervical ultrasound of the lingual and palatine tonsils. The diagnostic accuracy, number of correct biopsies, number of imaging modalities ordered, and time to final diagnosis are noted. Conclusion This randomized controlled study examines whether the implementation of transoral and cervical ultrasound of the palatine and lingual tonsils in patients with suspected oropharyngeal cancer will improve the diagnostic accuracy and have a clinical impact. This concerns more accurate initial diagnoses, more correct biopsies, fewer unnecessary scans, and fewer visits to the outpatient clinic.

Official title: Surgeon-performed Transoral and Cervical Ultrasound of the Palatine and Lingual Tonsils in Patients With Suspected Oropharyngeal Cancer - a Research Proposal for a Multicenter, Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-08-20

Completion Date

2027-05-01

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Ultrasound of the oropharynx

Ultrasound of the oropharynx in patients with suspected oropharyngeal cancer

Locations (4)

Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital

Aarhus, Denmark

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, Denmark

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology Northzealand Hospital

Hillerød, Denmark

Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital,

Køge, Denmark