Clinical trial NCT06314711: Ex Vivo 3D-ultrasound for Oropharyngeal Cancer
Official title: Tumor Volume and Margin Assessment with Ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* Four surgeons blinded to histopathology will rate each included case in terms of tumor visibility on ex vivo 3D US scans. If visible, the surgeons will mark the tumor and the healthy tissue.
* Tumor and margins will be correlated to histopathology pre- and post-formalin fixation on a subset of cases to explore the proportion of tissue shrinkage from formalin fixation.

Eligibility criteria: Inclusion Criteria:

* Patients surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma.

Exclusion Criteria:

* Patients from the QOLATI trial (NCT04124198)

Primary outcomes:
measure: Blind-assessed tumor size from fresh ex vivo US
timeFrame: day 1
measure: Blind-assessed deep and lateral margin measurements on fresh ex vivo US
timeFrame: day 1
Secondary outcomes:
measure: Fresh vs formalin-fixed ex vivo US tumor volume
timeFrame: day 1
measure: Margin involvement (categorical)
timeFrame: day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet
Study officials:
References:
citation: Makouei F, Agander TK, Ewertsen C, Sondergaard Svendsen MB, Norling R, Kaltoft M, Hansen AE, Rasmussen JH, Wessel I, Todsen T. 3D Ultrasound and MRI in Assessing Resection Margins during Tongue Cancer Surgery: A Research Protocol for a Clinical Diagnostic Accuracy Study. J Imaging. 2023 Aug 28;9(9):174. doi: 10.3390/jimaging9090174.