Randomized Study of Transoral and Cervical Ultrasound to Improve Diagnosis of Suspected Oropharyngeal Cancer

What this Trial Is About

The incidence of oropharyngeal cancer is increasing worldwide, and diagnosing this cancer can be difficult because small tumors often look like normal tissue in the palatine and lingual tonsils. This trial studies whether adding transoral and cervical ultrasound to the standard diagnostic workup improves accuracy and clinical outcomes for patients suspected of having oropharyngeal cancer. The study is a randomized controlled trial involving 170 patients across multiple hospital departments in Denmark. Participants are divided into two groups one receives standard diagnostics including clinical exams, biopsies, MRI, PETCT scans, and standard imaging the other group receives the same standard diagnostics plus transoral and cervical ultrasound of the palatine and lingual tonsils during the outpatient clinic visit. Ultrasound uses small high-frequency transducers for transoral scans and low-frequency transducers for cervical scans, performed by trained ENT surgeons following a specific protocol. During the study, participants undergo clinical examinations, biopsies if suspicious areas are found, and relevant imaging tests. Researchers collect data on diagnostic accuracy, biopsy results, tumor staging and size, number of diagnostic surgeries, outpatient visits, and time to confirmed diagnosis, with follow-up lasting six months after inclusion. The study also tracks imaging orders and compares outcomes between the ultrasound and control groups to assess if ultrasound can reduce unnecessary procedures and visits.

Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer