Transoral and neck ultrasound to find suspected oropharyngeal (throat) cancers
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Aarhus and 3 other locations) |
| Trial ID | NCT07548268 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus and 3 other locations
- Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiology — Copenhagen, Denmark (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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.