NCT05841966Completed
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 · Last updated 7 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 16 Feb 2023
- Start date
- 21 Feb 2023
- Primary completion date
- 29 Jan 2024
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Head and neck cancer
- NCT number
- NCT05841966
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 21 Feb 2023 to the primary completion date, 29 Jan 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to complete full surgical work-up including palatine- and lingual tonsillectomy.
Other
- Unable to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Århus University Hospital, Department of Otorhinolaryngology, Head & Neck Surgery Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet, Department of Otorhinolaryngology, Head & Neck Surgery & Audiology Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.