Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

Recruiting now · Not applicable

Conditions studied: Oropharyngeal Carcinoma, Ultrasound

In brief

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.

Key facts

Study ID

NCT07548268

Run by

Tobias Todsen

People needed

180

Starts

2025-08-20

Expected to finish

2027-05-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Department of Otorhinolaryngology, Head and Neck Surgery & Audiology — Copenhagen, Denmark (enrolling)
• Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital — Aarhus, 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

Full record on ClinicalTrials.gov

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