Surgeon-performed Outpatient Transoral and Transcervical Ultrasound of the Oropharynx

NCT05696314 | Completed

• 1 other identifier: Transoral Ultrasound
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Tumors detected by clinical evaluation, ultrasound, MRI, CT, and PET/CT compared to the reference standard histopathology results.

  Sub-location specific detection of tumors in the oropharynx will be assessed blinded to histopathology. The final histopathology diagnosis will typically be available within two weeks.

  2 weeks.

Secondary Outcomes (3)

• Greatest tumor diameter in millimeters estimated with clinical evaluation, ultrasound and MRI, and CT.

  1 minute

• Categorical T-stage estimated with clinical evaluation, ultrasound, and MRI, and CT.

  1 minute

• Tonsil and tongue base tumor volume estimated with clinical evaluation, ultrasound and MRI, and CT.

  1 minute

Other Outcomes (7)

• Comparison of tumor detection and size between MRI and CT

  1 year

• MRI and PET-CT scan quality

  1 year

• Ultrasound scan quality

  1 minute

Study Arms (1)

Outpatient Oropharynx Ultrasound

EXPERIMENTAL

Transoral and/or Transcervical ultrasound of the oropharynx

Diagnostic Test: Transoral Ultrasound; Diagnostic Test: Transcervical Ultrasound

Interventions

Transoral Ultrasound DIAGNOSTIC_TEST

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.

Outpatient Oropharynx Ultrasound

Transcervical Ultrasound DIAGNOSTIC_TEST

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.

Outpatient Oropharynx Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior radiotherapy to the oropharynx.
• Prior oropharynx cancer.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator

Study Sites (3)

Århus University Hospital, Department of Otorhinolaryngology, Head & Neck Surgery

Aarhus, 8200, Denmark

Location

Rigshospitalet, Department of Otorhinolaryngology, Head & Neck Surgery & Audiology

Copenhagen, 2100, Denmark

Location

Zealand University Hospital - Køge, Department of Otorhinolaryngology, Head and Neck Surgery

Køge, 4600, Denmark

Location

Related Publications (1)

• Garset-Zamani M, Norling R, Hahn CH, Agander TK, von Buchwald C, Todsen T. Transoral Ultrasound in the Outpatient Clinic for the Diagnostic Work-Up of Oropharyngeal Cancer: A Feasibility Study. Cancers (Basel). 2023 Nov 4;15(21):5292. doi: 10.3390/cancers15215292.

  PMID: 37958465 BACKGROUND

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Tonsillar Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic 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

Model Details: The intervention (transoral and transcervical ultrasound) is performed on all included patients. All patients will also receive a standard MRI of the oropharynx. All tumors will be biopsy verified.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 25, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)