RecruitingNot ApplicableNCT07548268

Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

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


Sponsor

Tobias Todsen

Enrollment

180 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Referred to outpatient cancer clinic with one of the following:
  • A scan (MR, CT, PET/CT) suggesting malignancy in the oropharynx. This being asymmetric metabolic activity on PET/CT, a tumor or asymmetry of the palatine and lingual tonsils on MR and CT (7).
  • Tumor suspicious findings (erosion/ulcus, tonsil asymmetry/hypertrophy).
  • Tumor-suspicious symptoms (pain of the oropharynx)
  • > 18 years of age.
  • Ability to understand and give informed consent.

Exclusion Criteria2

  • Prior oropharyngeal cancer
  • Prior radiation to the head and neck area

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTUltrasound 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07548268


Related Trials