Clinical trial · Interventional
Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Carcinoma | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ultrasound | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound of the oropharynx | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diagnostics with ultrasound of the oropharynx
- description
- 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
- interventionNames
- Diagnostic Test: Ultrasound of the oropharynx
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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