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Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer

NCT05698667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-05-06

No results posted yet for this study

Summary

The aim of the study was to examine the detection rate and tumor size evaluation in patients with suspected oropharynx cancer using a new technique with transoral ultrasound of the oropharynx. The new technique was compared to Magnetic Resonance Imaging (MRI). The study investigators included patients referred to a tertiary head \& neck cancer center in Copenhagen, Denmark, with suspicion of oropharynx cancer. Patients supplied written informed consent and were included and ultrasound scanned with local anesthesia in the outpatient clinic. Blinded assessment of MRI's was performed for tumor detection and compared to ultrasound with the reference standard being histopathology biopsy results.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Transoral ultrasound

Under local anesthetic with xylocaine spray in the oropharynx, the tonsils and tongue base are scanned with small-footprint, high-frequency ultrasound transducers (such as the 18XL5s hockey-stick from BK Medical)

DIAGNOSTIC_TEST

Transcervical ultrasound

The tongue base and tonsils are scanned externally via the neck, where a (preferably low-frequency) transducer is placed onto the skin above the hyoid bone to visualize the tongue base. The tonsils are visualized adjacent to the tongue base on either side and are located deep to the submandibular glands in a oblique coronal plane.

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
2021-10-01
Primary Completion
2022-05-01
Completion
2022-05-01

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 NCT05698667 on ClinicalTrials.gov