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Surgeon-performed Outpatient Transoral and Transcervical Ultrasound of the Oropharynx

NCT05696314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-10-03

No results posted yet for this study

Summary

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

  • Oropharynx Cancer
  • Tonsil Cancer
  • Base of the Tongue Tumor
  • Tonsil Hypertrophy
  • Tonsil Ulcer
  • Tonsil Neoplasm
  • Tonsil Lymphoma
  • Base of Tongue Carcinoma

Interventions

DIAGNOSTIC_TEST

Transoral Ultrasound

The oropharynx is scanned using high-frequency, small-footprint ultrasound transducers placed onto the suspected oropharynx sub-locations (e.g. tonsils or tongue base). Lidocaine spray or gel will be applied prior to scanning to reduce the gag reflex.

DIAGNOSTIC_TEST

Transcervical Ultrasound

Curved low-frequency ultrasound transducers will be placed on the submental region on the skin of the neck, and the tongue base will be visualized in the midline in transverse and sagittal planes. The tonsils will be visualized adjacent to the tongue base on either side in oblique transverse and oblique sagittal planes, deep to the submandibular glands.

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Tobias Todsen, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-07-01
Completion
2024-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696314 on ClinicalTrials.gov