Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTobias Todsen

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

• Prior oropharyngeal cancer

Prior radiation to the head and neck area

Trial design

Treatments tested in this trial

  • Ultrasound of the oropharynx

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tobias Todsen

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Aarhus University Hospital

Collaborator

Køge Hospital, Denmark

Collaborator

Hillerod Hospital, Denmark

Collaborator