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

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)

Transoral 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.

Transcervical ultrasound

Tobias Todsen, MD, PhD

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.

An explorative diagnostic study was performed at the Department of Otorhinolaryngology, Head \& Neck Surgery, Copenhagen University Hospital - Rigshospitalet, Denmark from October 1st, 2021, to April 30th, 2022. The study investigators invited adult patients from the outpatient cancer clinic referred with a suspicion of oropharynx cancer to participate in the study. At the study investigators' center, all head \& neck cancer patients receive diagnostic work-up which includes clinical exam, flexible laryngoscopy with narrow-band imaging, surgeon-performed neck ultrasound and biopsy and/or cytology with same-day results. Patients were enrolled after verbal and written consent and were offered an ultrasound examination of the oropharynx as an addition to the standard diagnostic workup in the outpatient clinic. All included patients also received an MRI of the head and neck. Clinical data including age, sex, smoking habits, alcohol consumption, date of MRI scan, and histopathology results were obtained from medical charts after inclusion.

Interventions included transoral ultrasound of the tonsils and base of tongue, conducted with BK5000 ultrasound machines using the X18L5s "hockey stick" transducer. Transcervical ultrasound was also performed in patients where a tongue base cancer was most likely. Standard linear neck transducers (X18L5) or a curved 9C2 transducer was used. The tonsils and tongue base were scanned in two planes if possible, and doppler flow was recorded as well. Ultrasound images were stored as video clips.

The detection of tumors with ultrasound was recorded as "positive" if a well-defined tumor was seen that was clearly visualized compared to the contralateral side. A "negative" result was given if no tumors were suspected on either side. An "inconclusive" result was given if a tumor was not clear, but there was suspicious asymmetry visualized. The anatomical sub-location of tumors were stratified into right and left tonsil, tongue base, overlapping tonsil and tongue base, and "other" sub-locations. "Other" sub-locations included the soft palate, uvula, oropharynx posterior wall, vallecula, anterior pharyngeal arch and posterior pharyngeal arch.

MRI was used as the reference test. An expert neuroradiologist blinded to ultrasound results and histopathology rated all tests for tumor detection in the oropharynx and tumor size in detected tumors.

Statistical analysis:

Tumor detection of oropharynx ultrasound and MRI will be compared using the histopathologic diagnosis (cancer or benign) as reference standard to calculate sensitivity, specificity, positive- and negative predictive values (PPV, NPV).

Inconclusive tests will be analyzed as a positive result due to the clinical consequences often leading to diagnostic tonsillectomy.

McNemar's test for differences between sensitivity, specificity, PPV and NPV between ultrasound and MRI will be calculated.

The greatest tumor diameter will be compared between ultrasound and MRI using scatter plots and the Pearson's R correlation coefficient. Tumor volumes calculated using the formula for an ellipse: π/6 \* craniocaudal \* anteroposterior \* mediolateral will be compared. Statistical analysis will be performed using R software version 4.2.2.

Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer

Surgeon-performed Outpatient Transoral and Transcervical Ultrasound for the Diagnostic Work-up of Oropharynx Cancer: a Feasibility Study

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

Greatest tumor diameter measured in millimeters.

Patients with benign tonsillar asymmetry (histopathology verified) correctly detected by a negative ultrasound or MRI test result.

The Novo Nordic Foundation

Rigshospitalet, Denmark

Principal Investigator

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Squamous Cell

Nasopharyngeal Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Nasopharyngeal Carcinoma

Mouth Neoplasms

Salivary Gland Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Nasopharyngeal Diseases

Respiratory Tract Diseases

Mouth Diseases

Salivary Gland Diseases

Respiratory Tract Neoplasms

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

The aim is to identify recurrence through serial monitoring patients with blood samples.

The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA

Liquid biopsy

Christian Grønhøj, MD, Ph.D

Christian Von Buchwald, MD, DMSc

This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.

Cell-free Tumor DNA in Head and Neck Cancer Patients

Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer

The primary outcome is to measure the percentage of head and neck squamous cell carcinomas that can be detected using a liquid biopsy (blood sample)

The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)

Copenhagen University Hospital, Denmark

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Christian von Buchwald

Clinical Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer	NCT05698667	Oropharynx Canc... Oropharynx Neop... Tonsil Cancer Tonsil Neoplasm Tonsil Hypertro... Tonsil Lymphoma Base of Tongue ... Base of Tongue ...	Transoral ultra... Transcervical u...	18 Years -	Rigshospitalet, Denmark
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark
Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer	NCT05698667	Oropharynx Canc... Oropharynx Neop... Tonsil Cancer Tonsil Neoplasm Tonsil Hypertro... Tonsil Lymphoma Base of Tongue ... Base of Tongue ...	Transoral ultra... Transcervical u...	18 Years -	Rigshospitalet, Denmark
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for oropharynx neoplasm