Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

NCT07548268 | Recruiting DMC

• 1 other identifier: VMK2501276
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Oropharyngeal Carcinoma; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy (sensitivity and specificity) in the control and intervention groups

  The follow-up time is six months from the day of study inclusion

Secondary Outcomes (7)

• % Number of positive biopsies

  On the day of the the first outpatient clinic visit.

• Tumor staging

  From indclusion untill MDT conference

• Tumor size

  From inclusion untill MRI result is present. No later than 2 moths after inclusion

• Number of patients needing diagnostic surgery

  From inclusion untill final diagnosis. No later than four moths after inclusion.

• Number of visits to the outpatient clinic

  From initial visit in the outpatient clinic untill completed diagnostic work-up. No later than 6 months after initial examination in the outpatient clinic

Study Arms (2)

Diagnostics with ultrasound of the oropharynx

EXPERIMENTAL

Diagnosis with ultrasound of the oropharynx. This including transoral ultrasound and transcervical ultrasound of the suspected area. This beeing either the palatine or lingual tonsils or both. 2.4 Transoral and cervical US of the lingual and palatine tonsils In the intervention group, US of the palatine and lingual tonsils will be performed in the outpatient clinic during the standard clinical examination. The scan is needed solely for the area of concern. When suspicion involves the palatine tonsils, scanning is limited to them; the same applies to the lingual tonsils. Always scan the contralateral side as a reference. Transoral US will be performed with small high-frequency transducers. Cervical US will be performed with low-frequency, high-depth penetration transducers. The transoral and cervical US scans will be performed according to the previously published protocol by Garset-Zamani et al. The investigators will utilize various US machines, including the Arietta 850 US Mach

Diagnostic Test: Ultrasound of the oropharynx

Control group

NO INTERVENTION

Standard clinical workup All patients will receive a standard clinical examination by a trained senior registrar or consultant ENT surgeon, regardless of trial arm allocation. All diagnostics will be aligned with the national guidelines for oropharyngeal cancer, including an head and neck surgeon-performed clinical examination (including fiberoptic laryngoscopy with narrow-band imaging and neck US), MRI/PET-CT, and biopsies. A biopsy is performed to obtain a diagnosis when the ENT surgeon identifies a suspicious area. The biopsy will be sent for a frozen section histopathological examination. Patients will undergo standard imaging (MR, PET/CT) for further confirmation of diagnosis if deemed relevant by the ENT surgeon. A final diagnosis, TNM stage, and treatment plan (surgery, radiotherapy, radio- and chemotherapy) are determined at the multidisciplinary team conference. Standard diagnostic workup for patients with a suspected oropharyngeal cancer.

Interventions

Ultrasound of the oropharynx DIAGNOSTIC_TEST

Ultrasound of the oropharynx in patients with suspected oropharyngeal cancer

Also known as: Transoral ultrasound

Diagnostics with ultrasound of the oropharynx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior oropharyngeal cancer
• Prior radiation to the head and neck area

Sponsors & Collaborators

• Tobias Todsen: lead
• Aarhus University Hospital: collaborator
• Køge Hospital, Denmark: collaborator
• Hillerod Hospital, Denmark: collaborator

Study Sites (4)

Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital

Aarhus, Denmark

NOT YET RECRUITING

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, 2100, 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

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, ENT consultant, Ph.D., associate professor

Model Details: 2.4 Randomization Patients will be randomized in two trial arms upon inclusion. Intervention group, trial arm A: Receive standard clinical examination (including flexible video-pharyngo-laryngoendoscopy and neck US) and transoral- and cervical US of the oropharynx. Control group, trial arm B: Receive standard clinical examination (including flexible video-pharyngo-laryngoendoscopy and neck US)

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: April 23, 2026
• Study Start: August 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (4)