Transoral and neck ultrasound to find suspected oropharyngeal (throat) cancers
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
Run by Copenhagen University Hospital, Rigshospitalet · NCT07548268 · Data updated 2026-11-12
This study will test whether adding transoral and neck ultrasound to the usual diagnostic tests helps doctors find oropharyngeal (throat) cancers more accurately in adults referred for suspicion of oropharyngeal cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Aarhus and 3 other locations) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | May 1, 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07548268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 referred to an outpatient cancer clinic for suspected oropharyngeal cancer (based on suspicious symptoms or abnormal CT, MRI, or PET/CT) who can give informed consent and have no prior oropharyngeal cancer or prior head and neck radiation are ideal candidates.
✕Probably not a fit
Patients with prior oropharyngeal cancer or prior head and neck radiation are excluded and may not benefit, and those with large obvious tumors on standard imaging may gain little additional diagnostic value from the ultrasound.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial is a randomized controlled study that will enroll 170 adults with suspected oropharyngeal cancer across multiple head and neck departments in Denmark. Participants are randomized to receive either standard diagnostic workup or standard workup plus transoral and cervical (neck) ultrasound of the palatine and lingual tonsils using high-frequency transducers. The study will compare diagnostic accuracy, the number of correct biopsies, the number of additional imaging tests ordered, and time to final diagnosis between the two groups. The goal is to determine whether adding this ultrasound approach changes clinical decision-making and patient pathways compared with current practice.
Why it matters
Potential benefit: If successful, the approach could speed up diagnosis and reduce unnecessary biopsies and additional imaging, lowering cost and patient discomfort.
How similar studies have gone: Previous smaller studies have shown that transoral and cervical ultrasound can detect palatine and lingual tonsil tumors more accurately than clinical exam and MRI, but its effect on clinical care has not been tested in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * • Prior oropharyngeal cancer * Prior radiation to the head and neck area
Where it's running
-
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Copenhagen, Denmark Recruiting -
Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital
Aarhus, Denmark Not yet recruiting -
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology Northzealand Hospital
Hillerød, Denmark Not yet recruiting -
Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital,
Køge, Denmark Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.