Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTobias Todsen
About this trial
Introduction The current diagnostic approach for patients with suspected oropharyngeal cancer involves a combination of clinical examination, tissue sampling, and relevant cross-sectional imaging. Previous studies have shown that transoral and cervical ultrasound (US) of the palatine and lingual tonsils has a better diagnostic accuracy than clinical investigation and magnetic resonance imaging (MRI) in patients with suspected oropharyngeal cancer, but it has not been established whether adding this scan to the diagnostic workup has a clinical impact.
Methods A randomized controlled study, including 170 patients at four different Head and Neck Hospital departments in Denmark. One group receives standard diagnostics (control group), and the other group receives standard diagnostics supplemented by transoral and cervical ultrasound of the lingual and palatine tonsils. The diagnostic accuracy, number of correct biopsies, number of imaging modalities ordered, and time to final diagnosis are noted.
Conclusion This randomized controlled study examines whether the implementation of transoral and cervical ultrasound of the palatine and lingual tonsils in patients with suspected oropharyngeal cancer will improve the diagnostic accuracy and have a clinical impact. This concerns more accurate initial diagnoses, more correct biopsies, fewer unnecessary scans, and fewer visits to the outpatient clinic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A scan (MR, CT, PET/CT) suggesting malignancy in the oropharynx. This being asymmetric metabolic activity on PET/CT, a tumor or asymmetry of the palatine and lingual tonsils on MR and CT (7).
Tumor suspicious findings (erosion/ulcus, tonsil asymmetry/hypertrophy).
Tumor-suspicious symptoms (pain of the oropharynx)
> 18 years of age.
Disqualifiers
• Prior oropharyngeal cancer
Prior radiation to the head and neck area
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound of the oropharynx
Diagnostic testUltrasound of the oropharynx in patients with suspected oropharyngeal cancer
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Diagnostics with ultrasound of the oropharynxExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Diagnostic accuracy
Diagnostic accuracy (sensitivity and specificity) in the control and intervention groups
Time frame
The follow-up time is six months from the day of study inclusionSecondary outcomes
1
% Number of positive biopsies
Number of patients recieving a sufficient biopsy during their visit in the outpatient clinic.
Time frame
On the day of the the first outpatient clinic visit.2
Tumor staging
Compare the ultrasound and clinical estimated tumor staging with the final size estimate made at the MDT conference and on MRI
Time frame
From indclusion untill MDT conference3
Tumor size
Comparison of tumor size in three dimensions (APxMLxCC) in mm in both groups and correlation with MRI measurements
Time frame
From inclusion untill MRI result is present. No later than 2 moths after inclusion4
Number of patients needing diagnostic surgery
Comparison of the number of patients needing diagnostic surgery inthe intervention and control groups.
Time frame
From inclusion untill final diagnosis. No later than four moths after inclusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tobias Todsen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Aarhus University Hospital
Collaborator
Køge Hospital, Denmark
Collaborator
Hillerod Hospital, Denmark
Collaborator
Source ClinicalTrials.gov