Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05698667
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-01-16
Brief Title:
Outpatient Ultrasound for the Diagnostic Work-up of Oropharynx Cancer
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Surgeon-performed Outpatient Transoral and Transcervical Ultrasound for the Diagnostic Work-up of Oropharynx Cancer a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 MRIs was performed for tumor detection and compared to ultrasound with the reference standard being histopathology biopsy results
Detailed 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 andor 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
McNemars 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 Pearsons R correlation coefficient Tumor volumes calculated using the formula for an ellipse π6 craniocaudal anteroposterior mediolateral will be compared Statistical analysis will be performed using R software version 422
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
McNemars 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 Pearsons R correlation coefficient Tumor volumes calculated using the formula for an ellipse π6 craniocaudal anteroposterior mediolateral will be compared Statistical analysis will be performed using R software version 422
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None