Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05698667 |
| Other study ID # |
Transoral US Feasibility |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
