Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Ultrasound trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment180 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Drugs / interventionsradiation
Locations4 sites (Aarhus and 3 other locations)
StatusRecruiting
StartedAugust 20, 2025
Main results expectedNovember 1, 2026
Study endsMay 1, 2027
Registry record updatedApril 23, 2026
Trial IDNCT07548268 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.