NCT05696314Completed
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
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 201 (actual)
- First submitted
- 16 Dec 2022
- Start date
- 1 Feb 2023
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Head and neck cancer
- NCT number
- NCT05696314
What you commit to
- Study type: Interventional
- Participants enrolled: 201
- From 1 Feb 2023 to the primary completion date, 1 Jul 2024
- 3 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
- Prior radiotherapy to the oropharynx.
- Prior oropharynx cancer.
- MRI of the oropharynx or PET-CT already performed 3 months prior to inclusion.
Who the study is looking for
- 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:
- Visible and/or palpable tumors of the oropharynx.
- Asymmetry of the tonsils or tongue base.
- Symptoms including dysphagia, throat pain, and/or referred otalgia where an oropharynx tumor is suspected but not clinically visible.
- Suspected cervical lymph node metastasis with no visible/palpable primary tumor.
- Lateral neck cysts in patients aged 40+ years.
- Adult patients aged 18+ years.
- Understands Danish or English and can give written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile 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 |
| Zealand University Hospital - Køge, Department of Otorhinolaryngology, Head and Neck Surgery Coordinator of this site? Confirm its status | Køge | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.