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
Sponsors and collaborators
Tobias Todsen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Aarhus University Hospital
Collaborator
Køge Hospital, Denmark
Collaborator
Hillerod Hospital, Denmark
Collaborator