Clinical trial · Interventional
Surgeon-performed Intraoperative Transoral Ultrasound for Cancer of Unknown Primary
Surgeon-performed Intraoperative Transoral Ultrasound in Patients With Suspected Head and Neck Squamous Cell Carcinoma of Unknown Primary: a Prospective Diagnostic Accuracy Study
- 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)
Adult patients suspected of Squamous Cell Carcinoma of Unknown Primary (SCCUP) will be prospectively enrolled at a tertiary head \& neck cancer center at Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. All patients will undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) prior to examination in general anesthesia. During general anesthesia, Intraoperative Transoral Ultrasound (ITUS) will be performed prior to panendoscopy. Detected tumors will be registered with specified oropharyngeal sub-locations. Blinded to ITUS, a consultant head \& neck surgeon will perform panendoscopy. After examination, the surgeon is unblinded to ultrasound results. Final histopathology results from location-specified biopsies performed will be used as reference standard. The overall detection rate will be compared between ITUS, panendoscopy, PET-CT and MRI with sensitivity and specificity analysis. Oropharynx sub-location specific detection rate of ITUS vs. panendoscopy will be compared with logistic regression analysis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Unknown Primary Site | Malignant Neoplasm of Unknown Primary | ALIAS | 0.90 |
| Unknown Primary Cancer | — | UNRESOLVED | — |
| Unknown Primary, Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transoral Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Transoral Ultrasound
- description
- Transoral ultrasound of the tonsils and tongue base under general anesthesia.
- interventionNames
- Diagnostic Test: Transoral Ultrasound
Primary outcomes (1)
- measure
- Increased detection rate by adding ITUS to panendoscopy
- timeFrame
- Within 2-4 weeks after panendoscopy.
- description
- The difference in proportion of patients with SCCUP where a primary tumor location is correctly detected by ITUS but not detected with panendoscopy alone.
Secondary outcomes (2)
- measure
- Ultrasonographic features of primary tonsil and tongue base tumors
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytology-verified cervical lymph node metastasis from squamous cell carcinoma in neck levels I-IV with HPV+ cytology. * Booked for panendoscopic examination under general anesthesia. * Pre-operative MRI and PET-CT available. Exclusion Criteria: * Unable to provide written informed consent. * Unable to complete full surgical work-up including palatine- and lingual tonsillectomy.
References
Publications (0)
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