NCT05698667

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

January 16, 2023

Last Update Submit

May 2, 2023

Conditions

Oropharynx CancerOropharynx NeoplasmTonsil CancerTonsil NeoplasmTonsil HypertrophyTonsil LymphomaBase of Tongue TumorBase of Tongue Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with oropharynx cancer detected by ultrasound compared to MRI

    Patients with cancer (histopathology verified) correctly detected by a positive ultrasound or MRI test result.

    Within two weeks.

Secondary Outcomes (2)

  • Greatest tumor diameter compared between ultrasound and MRI.

    1 day

  • Proportion of patients without oropharynx cancer detected by ultrasound compared to MRI

    Within three months.

Study Arms (1)

Oropharynx Ultrasound

EXPERIMENTAL

Transoral and transcervical ultrasound of the oropharynx, including the tonsils and tongue base.

Diagnostic Test: Transoral ultrasoundDiagnostic Test: Transcervical ultrasound

Interventions

Transoral ultrasoundDIAGNOSTIC_TEST

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)

Oropharynx Ultrasound
Transcervical ultrasoundDIAGNOSTIC_TEST

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.

Oropharynx Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visible and/or palpable tumor or asymmetry of the tonsils, tongue base or oropharynx.
  • Subjective symptoms of oropharynx cancer including dysphagia, odynophagia and/or referred otalgia.

You may not qualify if:

  • Unable to understand Danish or English.
  • Unable to provide written informed consent.
  • Age younger than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otorhinolaryngology, Head & Neck Surgery & Audiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Oropharyngeal NeoplasmsTonsillar Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Tobias Todsen, MD, PhD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

October 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

DK(1)