Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT06314711
Patients with biopsy-verified oropharyngeal squamous cell carcinomas treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).
Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.
The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
The purpose of the study is to determine the accuracy of ex vivo 3D ultrasound (US) for detecting and delineating tumor tissue of the tonsils and base of tongue post-operatively. This is a quick technique that may provide valuable information for the surgeon that can potentially improve treatment outcomes.
Placing the surgical specimen in a water bath allows for an US swipe to be performed without compressing the specimen. This reduces the deformation of the specimen by removing the pressure from conventional US scanning. A video clip can be captured by swiping across the specimen in the water bath. By motorizing this motion, the video can be converted into a 3D volume due to the known number of video frames and a constant swiping speed.
We will correlate the ex vivo 3D US scans to histopathology for the following analyses:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-frequency ultrasound of ex vivo specimen
Time frame: day 1
Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US
Time frame: day 1
Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.
Time frame: day 1
Comparison of tumor volumes (mm^3) estimated by ex vivo perioperative 3D-US before and after formalin fixation.
Time frame: day 1
Blinded evaluation of involved tumor margins (involved vs not involved)
Rigshospitalet, Denmark
Other
Tumor Volume and Margin Assessment with Ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
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