Clinical trial · Interventional
Surgeon-performed Outpatient Transoral and Transcervical Ultrasound of the Oropharynx
Surgeon-performed Outpatient Transoral and Transcervical Ultrasound Compared to MRI for the Diagnostic Workup of Primary Oropharynx Tumors: the SPOT-US Trial
NCT05696314CI-TRIAL-00081288SPOT-UScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of the study is to compare the sensitivity and specificity of transoral ultrasound, transcervical ultrasound, Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) in terms of detecting primary oropharynx tumors.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Base of the Tongue Tumor | Posterior Tongue Neoplasm | ALIAS | 0.90 |
| Base of Tongue Carcinoma | Posterior Tongue Carcinoma | ALIAS | 0.90 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Tonsil Cancer | Oropharyngeal Neoplasm | PROBABILISTIC | 0.70 |
| Tonsil Hypertrophy | — | UNRESOLVED | — |
| Tonsil Lymphoma | Tonsillar Lymphoma | ALIAS | 0.90 |
| Tonsil Neoplasm | Tonsillar Neoplasm | ALIAS | 0.90 |
| Tonsil Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcervical Ultrasound | Diagnostic Test | — | UNRESOLVED |
| Transoral Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Outpatient Oropharynx Ultrasound
- description
- Transoral and/or Transcervical ultrasound of the oropharynx
- interventionNames
- Diagnostic Test: Transoral Ultrasound
- Diagnostic Test: Transcervical Ultrasound
Primary outcomes (1)
- measure
- Tumors detected by clinical evaluation, ultrasound, MRI, CT, and PET/CT compared to the reference standard histopathology results.
- timeFrame
- 2 weeks.
- description
- Sub-location specific detection of tumors in the oropharynx will be assessed blinded to histopathology. The final histopathology diagnosis will typically be available within two weeks.
Secondary outcomes (3)
- measure
- Greatest tumor diameter in millimeters estimated with clinical evaluation, ultrasound and MRI, and CT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Initially assessed by a specialist otorhinolaryngologist with clinical suspicion of head and neck cancer and referred to fast-track cancer work-up. * Any of the following objective or subjective symptoms: 1. Visible and/or palpable tumors of the oropharynx. 2. Asymmetry of the tonsils or tongue base. 3. Symptoms including dysphagia, throat pain, and/or referred otalgia where an oropharynx tumor is suspected but not clinically visible. 4. Suspected cervical lymph node metastasis with no visible/palpable primary tumor. 5. Lateral neck cysts in patients aged 40+ years. * Adult patients aged 18+ years. * Understands Danish or English and can give written informed consent. Exclusion criteria: * Prior radiotherapy to the oropharynx. * Prior oropharynx cancer. * MRI of the oropharynx or PET-CT already performed 3 months prior to inclusion.
References
Publications (1)
- BACKGROUNDGarset-Zamani M, Norling R, Hahn CH, Agander TK, von Buchwald C, Todsen T. Transoral Ultrasound in the Outpatient Clinic for the Diagnostic Work-Up of Oropharyngeal Cancer: A Feasibility Study. Cancers (Basel). 2023 Nov 4;15(21):5292. doi: 10.3390/cancers15215292. PMID 37958465